ID

43419

Description

ODM derived from http://clinicaltrials.gov/show/NCT00402727

Link

http://clinicaltrials.gov/show/NCT00402727

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00402727 Abscess

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
Description

Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0162627
SNOMED CT 2011_0131
128936008
MedDRA 14.1
10052891
UMLS CUI 2011AA
C1514873
Inpatient care (regime/therapy)
Description

Hospitalization and

Data type

boolean

Alias
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
Initial parenteral therapy for at least 48 hours and
Description

Initial parenteral therapy for at least 48 hours and

Data type

boolean

Alias
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C1518896
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Meets at least one of the following criteria:
Description

Meets at least one of the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Involvement of deep soft tissue (e.g. fascial, muscle layers)
Description

Involvement of deep soft tissue (e.g. fascial, muscle layers)

Data type

boolean

Alias
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0205125
SNOMED CT 2011_0131
795002
UMLS CUI 2011AA
C0225317
SNOMED CT 2011_0131
87784001
LOINC Version 232
MTHU016974
UMLS CUI 2011AA
C1268198
SNOMED CT 2011_0131
120576005
UMLS CUI 2011AA
C0225358
SNOMED CT 2011_0131
86915006
Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
Description

Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
UMLS CUI 2011AA
C0969690
UMLS CUI 2011AA
C0011079
SNOMED CT 2011_0131
36777000
MedDRA 14.1
10067806
Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
Description

Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0009566
SNOMED CT 2011_0131
116223007
LOINC Version 232
MTHU008883
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0023890
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
UMLS CUI 2011AA
C0341439
SNOMED CT 2011_0131
328383001
MedDRA 14.1
10008953
UMLS CUI 2011AA
C0205470
SNOMED CT 2011_0131
37523008
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0035204
SNOMED CT 2011_0131
50043002
MedDRA 14.1
10038683
ICD-10-CM Version 2010
J98.9
ICD-9-CM Version 2011
519.9
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0042373
SNOMED CT 2011_0131
27550009
MedDRA 14.1
10047062
Duration of infection < 21 days
Description

Duration of infection < 21 days

Data type

boolean

Alias
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
Description

Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0037278
SNOMED CT 2011_0131
108365000
MedDRA 14.1
10040872
CTCAE 1105E
E11568
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C1518896
UMLS CUI 2011AA
C0338237
SNOMED CT 2011_0131
281789004
MedDRA 14.1
10067768
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
Description

Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage

Data type

boolean

Alias
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0000833
SNOMED CT 2011_0131
128477000
MedDRA 14.1
10000269
LOINC Version 232
MTHU022414
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0205231
SNOMED CT 2011_0131
41118005
UMLS CUI 2011AA
C0007642
SNOMED CT 2011_0131
128045006
MedDRA 14.1
10007882
ICD-10-CM Version 2010
L03.90
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0338237
SNOMED CT 2011_0131
281789004
MedDRA 14.1
10067768
UMLS CUI 2011AA
C0332287
SNOMED CT 2011_0131
20401003
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
Description

Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C0744130
MedDRA 14.1
10060803
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0031001
SNOMED CT 2011_0131
88058003
UMLS CUI 2011AA
C0439792
SNOMED CT 2011_0131
260858005
UMLS CUI 2011AA
C0456389
SNOMED CT 2011_0131
246115007
LOINC Version 232
MTHU010347
UMLS CUI 2011AA
CL414326
SNOMED CT 2011_0131
246171009
LOINC Version 232
MTHU017832
UMLS CUI 2011AA
C0040300
SNOMED CT 2011_0131
85756007
UMLS CUI 2011AA
C1517945
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0036658
SNOMED CT 2011_0131
373713005
LOINC Version 232
MTHU017277
UMLS CUI 2011AA
C1522446
UMLS CUI 2011AA
C0450094
UMLS CUI 2011AA
C0547054
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0029443
SNOMED CT 2011_0131
60168000
MedDRA 14.1
10031252
ICD-10-CM Version 2010
M86.9
ICD-9-CM Version 2011
730.20
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C2242472
SNOMED CT 2011_0131
111253001
ICD-10-CM Version 2010
M86.9
ICD-9-CM Version 2011
730.9
CTCAE 1105E
E11314
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C1609982
SNOMED CT 2011_0131
65320000
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0038895
Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
Description

Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:

Data type

boolean

Alias
UMLS CUI 2011AA
C0043241
SNOMED CT 2011_0131
76844004
MedDRA 14.1
10048038
LOINC Version 232
MTHU020838
CTCAE 1105E
E11635
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0038941
SNOMED CT 2011_0131
58126003
MedDRA 14.1
10036410
UMLS CUI 2011AA
C1264517
SNOMED CT 2011_0131
269406001
MedDRA 14.1
10036317
UMLS CUI 2011AA
C0005660
SNOMED CT 2011_0131
242605002
MedDRA 14.1
10020428
ICD-10-CM Version 2010
W50.3
ICD-9-CM Version 2011
E928.3
UMLS CUI 2011AA
C1302713
SNOMED CT 2011_0131
399907009
UMLS CUI 2011AA
C0043250
SNOMED CT 2011_0131
13924000
MedDRA 14.1
10052428
LOINC Version 232
MTHU001326
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
Description

Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0243132
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0003044
SNOMED CT 2011_0131
418975000
MedDRA 14.1
10002515
ICD-9-CM Version 2011
E906.5
UMLS CUI 2011AA
C0005660
SNOMED CT 2011_0131
242605002
MedDRA 14.1
10020428
ICD-10-CM Version 2010
W50.3
ICD-9-CM Version 2011
E928.3
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C1123023
SNOMED CT 2011_0131
39937001
LOINC Version 232
MTHU001414
UMLS CUI 2011AA
C0205145
SNOMED CT 2011_0131
10546003
LOINC Version 232
MTHU014632
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0005658
SNOMED CT 2011_0131
3404009
MedDRA 14.1
10004966
In addition, post-surgical/trauma wound infections must meet the following criteria:
Description

In addition, post-surgical/trauma wound infections must meet the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0038941
SNOMED CT 2011_0131
58126003
MedDRA 14.1
10036410
UMLS CUI 2011AA
C0332663
SNOMED CT 2011_0131
263904004
UMLS CUI 2011AA
C0043241
SNOMED CT 2011_0131
76844004
MedDRA 14.1
10048038
LOINC Version 232
MTHU020838
CTCAE 1105E
E11635
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
Description

Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma

Data type

boolean

Alias
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0205125
SNOMED CT 2011_0131
795002
UMLS CUI 2011AA
C0225317
SNOMED CT 2011_0131
87784001
LOINC Version 232
MTHU016974
UMLS CUI 2011AA
C1268198
SNOMED CT 2011_0131
120576005
UMLS CUI 2011AA
C0225358
SNOMED CT 2011_0131
86915006
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
At least one of the following criteria:
Description

At least one of the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Purulent drainage from the deep incision/trauma
Description

Purulent drainage from the deep incision/trauma

Data type

boolean

Alias
UMLS CUI 2011AA
C0439665
SNOMED CT 2011_0131
255316004
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
UMLS CUI 2011AA
C0205125
SNOMED CT 2011_0131
795002
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
Description

Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma

Data type

boolean

Alias
UMLS CUI 2011AA
C0205396
SNOMED CT 2011_0131
7882003
LOINC Version 232
MTHU014964
UMLS CUI 2011AA
C0029235
SNOMED CT 2011_0131
410653004
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0232920
SNOMED CT 2011_0131
261029002, 260984003
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C0430400
SNOMED CT 2011_0131
252398009
MedDRA 14.1
10061447
UMLS CUI 2011AA
CL427986
UMLS CUI 2011AA
C0040284
SNOMED CT 2011_0131
77601007
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
At least one of the following signs and symptoms:
Description

At least one of the following signs and symptoms:

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0220912
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Localized pain or tenderness
Description

Localized pain or tenderness

Data type

boolean

Alias
UMLS CUI 2011AA
C0520962
SNOMED CT 2011_0131
112104007
MedDRA 14.1
10069139
UMLS CUI 2011AA
C0392752
SNOMED CT 2011_0131
255471002
UMLS CUI 2011AA
C0234233
SNOMED CT 2011_0131
247348008
MedDRA 14.1
10043224
Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
Description

Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative

Data type

boolean

Alias
UMLS CUI 2011AA
C0015967
SNOMED CT 2011_0131
386661006
MedDRA 14.1
10005911
LOINC Version 232
MTHU013518
ICD-10-CM Version 2010
R50.9
ICD-9-CM Version 2011
780.60
CTCAE 1105E
E11102
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0038941
SNOMED CT 2011_0131
58126003
MedDRA 14.1
10036410
UMLS CUI 2011AA
C0175566
SNOMED CT 2011_0131
56116003
UMLS CUI 2011AA
C0582175
SNOMED CT 2011_0131
304292004
HL7 V3 2006_05
208600000X
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0855652
MedDRA 14.1
10061448
Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
Description

Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination

Data type

boolean

Alias
UMLS CUI 2011AA
C0000833
SNOMED CT 2011_0131
128477000
MedDRA 14.1
10000269
LOINC Version 232
MTHU022414
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0205125
SNOMED CT 2011_0131
795002
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0439851
SNOMED CT 2011_0131
255589003
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0035110
SNOMED CT 2011_0131
261554009
MedDRA 14.1
10042618
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0019637
UMLS CUI 2011AA
C1962945
SNOMED CT 2011_0131
363680008
MedDRA 14.1
10048064
Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
Description

Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205125
SNOMED CT 2011_0131
795002
UMLS CUI 2011AA
C0184898
SNOMED CT 2011_0131
34896006
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0037278
SNOMED CT 2011_0131
108365000
MedDRA 14.1
10040872
CTCAE 1105E
E11568
UMLS CUI 2011AA
C0582175
SNOMED CT 2011_0131
304292004
HL7 V3 2006_05
208600000X
UMLS CUI 2011AA
C1320929
SNOMED CT 2011_0131
405279007
HL7 V3 2006_05
ATTPHYS
Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)
Description

Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)

Data type

boolean

Alias
UMLS CUI 2011AA
C1827959
SNOMED CT 2011_0131
424685008
UMLS CUI 2011AA
C0043241
SNOMED CT 2011_0131
76844004
MedDRA 14.1
10048038
LOINC Version 232
MTHU020838
CTCAE 1105E
E11635
UMLS CUI 2011AA
C0043250
SNOMED CT 2011_0131
13924000
MedDRA 14.1
10052428
LOINC Version 232
MTHU001326
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0231242
SNOMED CT 2011_0131
255302009
UMLS CUI 2011AA
C0037278
SNOMED CT 2011_0131
108365000
MedDRA 14.1
10040872
CTCAE 1105E
E11568
Infected ischemic ulcers with at least one of the following conditions:
Description

Infected ischemic ulcers with at least one of the following conditions:

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0263555
SNOMED CT 2011_0131
13954005
MedDRA 14.1
10059084
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
Peripheral Vascular Diseases
Description

Peripheral vascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0085096
SNOMED CT 2011_0131
400047006
MedDRA 14.1
10034636
LOINC Version 232
MTHU020791
ICD-10-CM Version 2010
I73.9
ICD-9-CM Version 2011
443.9
Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
Description

Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0012655
SNOMED CT 2011_0131
76522002
UMLS CUI 2011AA
C0011127
SNOMED CT 2011_0131
399912005
MedDRA 14.1
10011985
LOINC Version 232
MTHU021397
ICD-10-CM Version 2010
L89
ICD-9-CM Version 2011
707.00
UMLS CUI 2011AA
C0030486
SNOMED CT 2011_0131
60389000
MedDRA 14.1
10033892
LOINC Version 232
MTHU020806
ICD-10-CM Version 2010
G82.20
ICD-9-CM Version 2011
344.1
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
Presence of at least 3 of the following signs or symptoms:
Description

Presence of at least 3 of the following signs or symptoms:

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0220912
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Purulent drainage or discharge
Description

Purulent drainage or discharge

Data type

boolean

Alias
UMLS CUI 2011AA
C0439665
SNOMED CT 2011_0131
255316004
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
UMLS CUI 2011AA
C0333274
SNOMED CT 2011_0131
35013009
MedDRA 14.1
10037569
Erythema extending > 1 cm from the wound edge
Description

Erythema extending > 1 cm from the wound edge

Data type

boolean

Alias
UMLS CUI 2011AA
C0041834
SNOMED CT 2011_0131
70819003
MedDRA 14.1
10015150
ICD-10-CM Version 2010
L53.9
ICD-9-CM Version 2011
695.9
UMLS CUI 2011AA
C0439792
SNOMED CT 2011_0131
260858005
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0475210
SNOMED CT 2011_0131
258672001
UMLS CUI 2011AA
C0043250
SNOMED CT 2011_0131
13924000
MedDRA 14.1
10052428
LOINC Version 232
MTHU001326
UMLS CUI 2011AA
C0205154
SNOMED CT 2011_0131
57183005
Fluctuance
Description

Fluctuance

Data type

boolean

Alias
UMLS CUI 2011AA
C0949036
MedDRA 14.1
10051723
Pain or tenderness to palpation
Description

Pain or tenderness to palpation

Data type

boolean

Alias
UMLS CUI 2011AA
C0030193
SNOMED CT 2011_0131
22253000
MedDRA 14.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE 1105E
E11167
UMLS CUI 2011AA
C0234233
SNOMED CT 2011_0131
247348008
MedDRA 14.1
10043224
UMLS CUI 2011AA
C0030247
SNOMED CT 2011_0131
113011001
Swelling or induration
Description

Swelling or induration

Data type

boolean

Alias
UMLS CUI 2011AA
C0038999
SNOMED CT 2011_0131
442672001
MedDRA 14.1
10042674
UMLS CUI 2011AA
C0332534
SNOMED CT 2011_0131
45147008
MedDRA 14.1
10060708
Fever, defined as body temperature
Description

Fever, defined as body temperature

Data type

boolean

Alias
UMLS CUI 2011AA
C0015967
SNOMED CT 2011_0131
386661006
MedDRA 14.1
10005911
LOINC Version 232
MTHU013518
ICD-10-CM Version 2010
R50.9
ICD-9-CM Version 2011
780.60
CTCAE 1105E
E11102
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0005903
SNOMED CT 2011_0131
386725007
LOINC Version 232
MTHU001362
> 37.5°C (axillary)
Description

> 37.5°C (axillary)

Data type

boolean

Alias
UMLS CUI 2011AA
C0439237
SNOMED CT 2011_0131
258710007
HL7 V3 2006_05
CEL
UMLS CUI 2011AA
CL317948
> 38°C (orally)
Description

> 38°C (orally)

Data type

boolean

Alias
UMLS CUI 2011AA
C0439237
SNOMED CT 2011_0131
258710007
HL7 V3 2006_05
CEL
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
> 38.5°C (tympanically) or
Description

> 38.5°C (tympanically) or

Data type

boolean

Alias
UMLS CUI 2011AA
C0439237
SNOMED CT 2011_0131
258710007
HL7 V3 2006_05
CEL
UMLS CUI 2011AA
C0041445
SNOMED CT 2011_0131
42859004
LOINC Version 232
MTHU014731
> 39°C (rectally)
Description

> 39°C (rectally)

Data type

boolean

Alias
UMLS CUI 2011AA
C0439237
SNOMED CT 2011_0131
258710007
HL7 V3 2006_05
CEL
UMLS CUI 2011AA
C0205052
SNOMED CT 2011_0131
255582007
Or
Description

OR

Data type

boolean

Alias
UMLS CUI 2011AA
CL414906
Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or
Description

Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or

Data type

boolean

Alias
UMLS CUI 2011AA
CL414623
UMLS CUI 2011AA
C0205100
SNOMED CT 2011_0131
14414005
UMLS CUI 2011AA
C1271681
SNOMED CT 2011_0131
391558003
MedDRA 14.1
10060297
>15 % immature neutrophils (bands) regardless of total peripheral WBC count
Description

>15 % immature neutrophils (bands) regardless of total peripheral WBC count

Data type

boolean

Alias
UMLS CUI 2011AA
CL429329
UMLS CUI 2011AA
C0432611
SNOMED CT 2011_0131
259712009
UMLS CUI 2011AA
C1554079
HL7 V3 2006_05
I
UMLS CUI 2011AA
C0205100
SNOMED CT 2011_0131
14414005
UMLS CUI 2011AA
C1271681
SNOMED CT 2011_0131
391558003
MedDRA 14.1
10060297
C-Reactive Protein Measurement
Description

C reactive protein (CRP) >20 mg/L

Data type

boolean

Alias
UMLS CUI 2011AA
C0201657
SNOMED CT 2011_0131
55235003
MedDRA 14.1
10006824
Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
Description

Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0370003
SNOMED CT 2011_0131
123038009
LOINC Version 232
MTHU010726
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C0430400
SNOMED CT 2011_0131
252398009
MedDRA 14.1
10061447
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
CL419348
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0439665
SNOMED CT 2011_0131
255316004
UMLS CUI 2011AA
C0520510
SNOMED CT 2011_0131
260769002
LOINC Version 232
MTHU013790
HL7 V3 2006_05
MAT
UMLS CUI 2011AA
C0040300
SNOMED CT 2011_0131
85756007
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0010468
SNOMED CT 2011_0131
68688001
UMLS CUI 2011AA
C0205148
SNOMED CT 2011_0131
410679008
LOINC Version 232
MTHU014970
UMLS CUI 2011AA
C0041582
SNOMED CT 2011_0131
10045285
MedDRA 14.1
10045285
LOINC Version 232
MTHU022920
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL428482
Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
Description

Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.

Data type

boolean

Alias
UMLS CUI 2011AA
C0444921
SNOMED CT 2011_0131
261773006
UMLS CUI 2011AA
C0037278
SNOMED CT 2011_0131
108365000
MedDRA 14.1
10040872
CTCAE 1105E
E11568
UMLS CUI 2011AA
C0679106
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205453
SNOMED CT 2011_0131
65607009
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
Description

Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0013103
SNOMED CT 2011_0131
122462000
UMLS CUI 2011AA
C0011079
SNOMED CT 2011_0131
36777000
MedDRA 14.1
10067806
UMLS CUI 2011AA
C0043241
SNOMED CT 2011_0131
76844004
MedDRA 14.1
10048038
LOINC Version 232
MTHU020838
CTCAE 1105E
E11635
UMLS CUI 2011AA
C0000833
SNOMED CT 2011_0131
128477000
MedDRA 14.1
10000269
LOINC Version 232
MTHU022414
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1555447
HL7 V3 2006_05
MEDNEC
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL428482
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)
Description

Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0430056
SNOMED CT 2011_0131
167252002
MedDRA 14.1
10036576
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
The following skin and skin structure infections:
Description

The following skin and skin structure infections:

Data type

boolean

Alias
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0037278
SNOMED CT 2011_0131
108365000
MedDRA 14.1
10040872
CTCAE 1105E
E11568
Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
Description

Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0238124
SNOMED CT 2011_0131
52486002
MedDRA 14.1
10028885
ICD-10-CM Version 2010
M72.6
ICD-9-CM Version 2011
728.86
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0238419
SNOMED CT 2011_0131
398318005
MedDRA 14.1
10017068
ICD-10-CM Version 2010
N49.3
UMLS CUI 2011AA
C0276085
SNOMED CT 2011_0131
17732003
MedDRA 14.1
10069756
UMLS CUI 2011AA
C0854084
MedDRA 14.1
10028888
UMLS CUI 2011AA
C1622996
SNOMED CT 2011_0131
413861006
UMLS CUI 2011AA
C0238124
SNOMED CT 2011_0131
52486002
MedDRA 14.1
10028885
ICD-10-CM Version 2010
M72.6
ICD-9-CM Version 2011
728.86
Burn wound infections
Description

Burn wound infections

Data type

boolean

Alias
UMLS CUI 2011AA
C0006434
SNOMED CT 2011_0131
48333001
MedDRA 14.1
10006634
LOINC Version 232
MTHU007829
ICD-10-CM Version 2010
T30.0
ICD-9-CM Version 2011
949.0
CTCAE 1105E
E11669
UMLS CUI 2011AA
C0043241
SNOMED CT 2011_0131
76844004
MedDRA 14.1
10048038
LOINC Version 232
MTHU020838
CTCAE 1105E
E11635
Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
Description

Secondary infections of a chronic skin disease (e.g. atopic dermatitis)

Data type

boolean

Alias
UMLS CUI 2011AA
C0442886
SNOMED CT 2011_0131
264569006
MedDRA 14.1
10062158
UMLS CUI 2011AA
C1290009
SNOMED CT 2011_0131
128236002
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included
Description

Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0444752
SNOMED CT 2011_0131
261389007
UMLS CUI 2011AA
C0278403
SNOMED CT 2011_0131
71966008
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C1145640
SNOMED CT 2011_0131
52124006
UMLS CUI 2011AA
C1828453
SNOMED CT 2011_0131
424921004
UMLS CUI 2011AA
CL381593
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0175649
SNOMED CT 2011_0131
53350007
UMLS CUI 2011AA
C0699733
SNOMED CT 2011_0131
49062001
LOINC Version 232
MTHU020022
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Infections where a surgical procedure alone is definitive therapy
Description

Infections where a surgical procedure alone is definitive therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
CL426229
Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
Description

Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0443334
SNOMED CT 2011_0131
263914008
UMLS CUI 2011AA
C0037278
SNOMED CT 2011_0131
108365000
MedDRA 14.1
10040872
CTCAE 1105E
E11568
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0016436
SNOMED CT 2011_0131
13600006
MedDRA 14.1
10016936
UMLS CUI 2011AA
C0016867
SNOMED CT 2011_0131
112650006
MedDRA 14.1
10017557
ICD-10-CM Version 2010
L02.92
UMLS CUI 2011AA
C0007078
SNOMED CT 2011_0131
41570003
MedDRA 14.1
10007247
UMLS CUI 2011AA
C0205352
SNOMED CT 2011_0131
13673007
UMLS CUI 2011AA
C0000833
SNOMED CT 2011_0131
128477000
MedDRA 14.1
10000269
LOINC Version 232
MTHU022414
UMLS CUI 2011AA
C0205124
SNOMED CT 2011_0131
26283006
UMLS CUI 2011AA
C0007642
SNOMED CT 2011_0131
128045006
MedDRA 14.1
10007882
ICD-10-CM Version 2010
L03.90
Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
Description

Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0034428
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0026458
SNOMED CT 2011_0131
90614001
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
Description

Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0268317
SNOMED CT 2011_0131
75066002
UMLS CUI 2011AA
C0920027
MedDRA 14.1
10050279
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
CL414314
SNOMED CT 2011_0131
89519005
LOINC Version 232
MTHU006777
Severe, life threatening disease with a life expectancy of < 2 months
Description

Severe, life threatening disease with a life expectancy of < 2 months

Data type

boolean

Alias
UMLS CUI 2011AA
C2711184
SNOMED CT 2011_0131
442452003
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0547044
SNOMED CT 2011_0131
263796003
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Immunosuppression including:
Description

Immunosuppression including:

Data type

boolean

Alias
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
Known neutropenia (neutrophil count < 1000/µL)
Description

Known neutropenia (neutrophil count < 1000/µL)

Data type

boolean

Alias
UMLS CUI 2011AA
C0853697
MedDRA 14.1
10029366
CTCAE 1105E
E12198
UMLS CUI 2011AA
C0200633
SNOMED CT 2011_0131
30630007
MedDRA 14.1
10029363
Known lymphopenia with absolute CD4+ T cell count < 200/mm3
Description

Known lymphopenia with absolute CD4+ T cell count < 200/mm3

Data type

boolean

Alias
UMLS CUI 2011AA
C0024312
SNOMED CT 2011_0131
48813009
MedDRA 14.1
10025327
ICD-10-CM Version 2010
D72.810
ICD-9-CM Version 2011
288.51
CTCAE 1105E
E12190
UMLS CUI 2011AA
C0243009
CTCAE 1105E
MTHU112269
Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
Description

Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)

Data type

boolean

Alias
UMLS CUI 2011AA
C0001175
SNOMED CT 2011_0131
62479008
MedDRA 14.1
10000565
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C0887947
SNOMED CT 2011_0131
416234007
Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
Description

Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
Any other congenital or acquired immune defect or immunosuppression
Description

Any other congenital or acquired immune defect or immunosuppression

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0009678
UMLS CUI 2011AA
C0439661
SNOMED CT 2011_0131
255396000
UMLS CUI 2011AA
C0021053
SNOMED CT 2011_0131
71922006
MedDRA 14.1
10021425
ICD-10-CM Version 2010
D89.9
ICD-9-CM Version 2011
279.9
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
Description

Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1306571
SNOMED CT 2011_0131
59927004
MedDRA 14.1
10056542
UMLS CUI 2011AA
C4050412
UMLS CUI 2011AA
C0439106
SNOMED CT 2011_0131
257962003
UMLS CUI 2011AA
C0438717
MedDRA 14.1
10054889
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C1632851
SNOMED CT 2011_0131
417929005
UMLS CUI 2011AA
C1519815
Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
Description

Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min

Data type

boolean

Alias
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C0444686
SNOMED CT 2011_0131
258090004
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
Description

Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])

Data type

boolean

Alias
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C1287082
SNOMED CT 2011_0131
365417009
UMLS CUI 2011AA
C1579436
UMLS CUI 2011AA
C0360703
SNOMED CT 2011_0131
372855004
UMLS CUI 2011AA
C0034414
SNOMED CT 2011_0131
372697008
LOINC Version 232
MTHU005039
UMLS CUI 2011AA
C0033216
SNOMED CT 2011_0131
372589008
LOINC Version 232
MTHU005035
UMLS CUI 2011AA
C0002598
SNOMED CT 2011_0131
372821002
LOINC Version 232
MTHU004841
UMLS CUI 2011AA
C0037707
SNOMED CT 2011_0131
372911006
LOINC Version 232
MTHU003385
UMLS CUI 2011AA
C0040615
SNOMED CT 2011_0131
10784006, 372482001
LOINC Version 232
MTHU003337
UMLS CUI 2011AA
C0018546
SNOMED CT 2011_0131
386837002
LOINC Version 232
MTHU005005
UMLS CUI 2011AA
C0003290
SNOMED CT 2011_0131
373253007
LOINC Version 232
MTHU001920
UMLS CUI 2011AA
C1136254
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
UMLS CUI 2011AA
C0030863
SNOMED CT 2011_0131
372699006
UMLS CUI 2011AA
C0120726
SNOMED CT 2011_0131
372527008
UMLS CUI 2011AA
C0019590
SNOMED CT 2011_0131
372806008
LOINC Version 232
MTHU003328
UMLS CUI 2011AA
C0085173
SNOMED CT 2011_0131
387089004
LOINC Version 232
MTHU003387
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0072916
SNOMED CT 2011_0131
387164008
LOINC Version 232
MTHU012783
UMLS CUI 2011AA
C0042674
UMLS CUI 2011AA
C0677510
SNOMED CT 2011_0131
260317009
UMLS CUI 2011AA
C0301371
SNOMED CT 2011_0131
373748003
Uncorrected hypokalemia
Description

Uncorrected hypokalemia

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1947976
UMLS CUI 2011AA
C0020621
SNOMED CT 2011_0131
43339004
MedDRA 14.1
10021015
ICD-10-CM Version 2010
E87.6
ICD-9-CM Version 2011
276.8
CTCAE 1105E
E12327
Clinically relevant bradycardia
Description

Clinically relevant bradycardia

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0428977
SNOMED CT 2011_0131
48867003
MedDRA 14.1
10006093
ICD-10-CM Version 2010
R00.1
Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
Description

Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C1096403
MedDRA 14.1
10053222
UMLS CUI 2011AA
CL384716
Previous history of symptomatic arrhythmias
Description

Previous history of symptomatic arrhythmias

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
Previous history of tendon disease/disorder with quinolones
Description

Previous history of tendon disease/disorder with quinolones

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0151936
SNOMED CT 2011_0131
68172002
MedDRA 14.1
10043239
UMLS CUI 2011AA
C0034428
Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
Description

Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0854606
MedDRA 14.1
10042933
UMLS CUI 2011AA
C1692886
SNOMED CT 2011_0131
372938004
MedDRA 14.1
10053555
ICD-10-CM Version 2010
M00.9
ICD-9-CM Version 2011
711.0
Requiring therapy with probenecid
Description

Requiring therapy with probenecid

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0033209
SNOMED CT 2011_0131
387365004
LOINC Version 232
MTHU007603
Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
Description

Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0279516
SNOMED CT 2011_0131
419241000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205453
SNOMED CT 2011_0131
65607009
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0438286
SNOMED CT 2011_0131
266721009
MedDRA 14.1
10063670
UMLS CUI 2011AA
C0332271
SNOMED CT 2011_0131
230993007
UMLS CUI 2011AA
C0037088
SNOMED CT 2011_0131
404684003
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0430400
SNOMED CT 2011_0131
252398009
MedDRA 14.1
10061447
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0546816
SNOMED CT 2011_0131
130965009
UMLS CUI 2011AA
C0450254
SNOMED CT 2011_0131
264418008
UMLS CUI 2011AA
C0231204
SNOMED CT 2011_0131
131196009
HL7 V3 2006_05
S
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1136254
SNOMED CT 2011_0131
250428009
LOINC Version 232
MTHU014499
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0949665
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0282215
SNOMED CT 2011_0131
406778007
UMLS CUI 2011AA
C0597979
SNOMED CT 2011_0131
79744009
Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
Description

Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen

Data type

boolean

Alias
UMLS CUI 2011AA
C0343401
SNOMED CT 2011_0131
266096002
MedDRA 14.1
10027508
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C1955827
UMLS CUI 2011AA
C0038174
SNOMED CT 2011_0131
60875001
UMLS CUI 2011AA
C1265175
SNOMED CT 2011_0131
113727004
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0205409
SNOMED CT 2011_0131
46651001
UMLS CUI 2011AA
C0450254
SNOMED CT 2011_0131
264418008
Previous enrolment in this study
Description

Previous enrolment in this study

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Participation in any clinical investigational drug study within 4 weeks of screening
Description

Participation in any clinical investigational drug study within 4 weeks of screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1409616
Previous history of seizure disorders
Description

Previous history of seizure disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
Item
Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0162627 (UMLS CUI 2011AA)
128936008 (SNOMED CT 2011_0131)
10052891 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
Hospitalization and
Item
Inpatient care (regime/therapy)
boolean
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
Initial parenteral therapy for at least 48 hours and
Item
Initial parenteral therapy for at least 48 hours and
boolean
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C1518896 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Meets at least one of the following criteria:
Item
Meets at least one of the following criteria:
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Involvement of deep soft tissue (e.g. fascial, muscle layers)
Item
Involvement of deep soft tissue (e.g. fascial, muscle layers)
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C1268198 (UMLS CUI 2011AA)
120576005 (SNOMED CT 2011_0131)
C0225358 (UMLS CUI 2011AA)
86915006 (SNOMED CT 2011_0131)
Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
Item
Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
boolean
C1514873 (UMLS CUI 2011AA)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0969690 (UMLS CUI 2011AA)
C0011079 (UMLS CUI 2011AA)
36777000 (SNOMED CT 2011_0131)
10067806 (MedDRA 14.1)
Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
Item
Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
boolean
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0009566 (UMLS CUI 2011AA)
116223007 (SNOMED CT 2011_0131)
MTHU008883 (LOINC Version 232)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C1522601 (UMLS CUI 2011AA)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
C0341439 (UMLS CUI 2011AA)
328383001 (SNOMED CT 2011_0131)
10008953 (MedDRA 14.1)
C0205470 (UMLS CUI 2011AA)
37523008 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0042373 (UMLS CUI 2011AA)
27550009 (SNOMED CT 2011_0131)
10047062 (MedDRA 14.1)
Duration of infection < 21 days
Item
Duration of infection < 21 days
boolean
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
Item
Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C1514873 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C1518896 (UMLS CUI 2011AA)
C0338237 (UMLS CUI 2011AA)
281789004 (SNOMED CT 2011_0131)
10067768 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
Item
Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
boolean
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205231 (UMLS CUI 2011AA)
41118005 (SNOMED CT 2011_0131)
C0007642 (UMLS CUI 2011AA)
128045006 (SNOMED CT 2011_0131)
10007882 (MedDRA 14.1)
L03.90 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0338237 (UMLS CUI 2011AA)
281789004 (SNOMED CT 2011_0131)
10067768 (MedDRA 14.1)
C0332287 (UMLS CUI 2011AA)
20401003 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
Item
Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
boolean
C0744130 (UMLS CUI 2011AA)
10060803 (MedDRA 14.1)
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0031001 (UMLS CUI 2011AA)
88058003 (SNOMED CT 2011_0131)
C0439792 (UMLS CUI 2011AA)
260858005 (SNOMED CT 2011_0131)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
CL414326 (UMLS CUI 2011AA)
246171009 (SNOMED CT 2011_0131)
MTHU017832 (LOINC Version 232)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C1517945 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0036658 (UMLS CUI 2011AA)
373713005 (SNOMED CT 2011_0131)
MTHU017277 (LOINC Version 232)
C1522446 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C0547054 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0029443 (UMLS CUI 2011AA)
60168000 (SNOMED CT 2011_0131)
10031252 (MedDRA 14.1)
M86.9 (ICD-10-CM Version 2010)
730.20 (ICD-9-CM Version 2011)
C1516879 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C2242472 (UMLS CUI 2011AA)
111253001 (SNOMED CT 2011_0131)
M86.9 (ICD-10-CM Version 2010)
730.9 (ICD-9-CM Version 2011)
E11314 (CTCAE 1105E)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C1609982 (UMLS CUI 2011AA)
65320000 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
Item
Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
boolean
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0038941 (UMLS CUI 2011AA)
58126003 (SNOMED CT 2011_0131)
10036410 (MedDRA 14.1)
C1264517 (UMLS CUI 2011AA)
269406001 (SNOMED CT 2011_0131)
10036317 (MedDRA 14.1)
C0005660 (UMLS CUI 2011AA)
242605002 (SNOMED CT 2011_0131)
10020428 (MedDRA 14.1)
W50.3 (ICD-10-CM Version 2010)
E928.3 (ICD-9-CM Version 2011)
C1302713 (UMLS CUI 2011AA)
399907009 (SNOMED CT 2011_0131)
C0043250 (UMLS CUI 2011AA)
13924000 (SNOMED CT 2011_0131)
10052428 (MedDRA 14.1)
MTHU001326 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
Item
Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0243132 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0038895 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0003044 (UMLS CUI 2011AA)
418975000 (SNOMED CT 2011_0131)
10002515 (MedDRA 14.1)
E906.5 (ICD-9-CM Version 2011)
C0005660 (UMLS CUI 2011AA)
242605002 (SNOMED CT 2011_0131)
10020428 (MedDRA 14.1)
W50.3 (ICD-10-CM Version 2010)
E928.3 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C1123023 (UMLS CUI 2011AA)
39937001 (SNOMED CT 2011_0131)
MTHU001414 (LOINC Version 232)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0005658 (UMLS CUI 2011AA)
3404009 (SNOMED CT 2011_0131)
10004966 (MedDRA 14.1)
In addition, post-surgical/trauma wound infections must meet the following criteria:
Item
In addition, post-surgical/trauma wound infections must meet the following criteria:
boolean
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0038941 (UMLS CUI 2011AA)
58126003 (SNOMED CT 2011_0131)
10036410 (MedDRA 14.1)
C0332663 (UMLS CUI 2011AA)
263904004 (SNOMED CT 2011_0131)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
Item
Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C1268198 (UMLS CUI 2011AA)
120576005 (SNOMED CT 2011_0131)
C0225358 (UMLS CUI 2011AA)
86915006 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
At least one of the following criteria:
Item
At least one of the following criteria:
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Purulent drainage from the deep incision/trauma
Item
Purulent drainage from the deep incision/trauma
boolean
C0439665 (UMLS CUI 2011AA)
255316004 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
Item
Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
boolean
C0205396 (UMLS CUI 2011AA)
7882003 (SNOMED CT 2011_0131)
MTHU014964 (LOINC Version 232)
C0029235 (UMLS CUI 2011AA)
410653004 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0232920 (UMLS CUI 2011AA)
261029002, 260984003 (SNOMED CT 2011_0131)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0430400 (UMLS CUI 2011AA)
252398009 (SNOMED CT 2011_0131)
10061447 (MedDRA 14.1)
CL427986 (UMLS CUI 2011AA)
C0040284 (UMLS CUI 2011AA)
77601007 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
At least one of the following signs and symptoms:
Item
At least one of the following signs and symptoms:
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Localized pain or tenderness
Item
Localized pain or tenderness
boolean
C0520962 (UMLS CUI 2011AA)
112104007 (SNOMED CT 2011_0131)
10069139 (MedDRA 14.1)
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0234233 (UMLS CUI 2011AA)
247348008 (SNOMED CT 2011_0131)
10043224 (MedDRA 14.1)
Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
Item
Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
boolean
C0015967 (UMLS CUI 2011AA)
386661006 (SNOMED CT 2011_0131)
10005911 (MedDRA 14.1)
MTHU013518 (LOINC Version 232)
R50.9 (ICD-10-CM Version 2010)
780.60 (ICD-9-CM Version 2011)
E11102 (CTCAE 1105E)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0038941 (UMLS CUI 2011AA)
58126003 (SNOMED CT 2011_0131)
10036410 (MedDRA 14.1)
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0582175 (UMLS CUI 2011AA)
304292004 (SNOMED CT 2011_0131)
208600000X (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0855652 (UMLS CUI 2011AA)
10061448 (MedDRA 14.1)
Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
Item
Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
boolean
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0439851 (UMLS CUI 2011AA)
255589003 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0035110 (UMLS CUI 2011AA)
261554009 (SNOMED CT 2011_0131)
10042618 (MedDRA 14.1)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0019637 (UMLS CUI 2011AA)
C1962945 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
10048064 (MedDRA 14.1)
Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
Item
Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0582175 (UMLS CUI 2011AA)
304292004 (SNOMED CT 2011_0131)
208600000X (HL7 V3 2006_05)
C1320929 (UMLS CUI 2011AA)
405279007 (SNOMED CT 2011_0131)
ATTPHYS (HL7 V3 2006_05)
Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)
Item
Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)
boolean
C1827959 (UMLS CUI 2011AA)
424685008 (SNOMED CT 2011_0131)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C0043250 (UMLS CUI 2011AA)
13924000 (SNOMED CT 2011_0131)
10052428 (MedDRA 14.1)
MTHU001326 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL414621 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0231242 (UMLS CUI 2011AA)
255302009 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
Infected ischemic ulcers with at least one of the following conditions:
Item
Infected ischemic ulcers with at least one of the following conditions:
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0263555 (UMLS CUI 2011AA)
13954005 (SNOMED CT 2011_0131)
10059084 (MedDRA 14.1)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
Peripheral vascular disease
Item
Peripheral Vascular Diseases
boolean
C0085096 (UMLS CUI 2011AA)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
Item
Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0012655 (UMLS CUI 2011AA)
76522002 (SNOMED CT 2011_0131)
C0011127 (UMLS CUI 2011AA)
399912005 (SNOMED CT 2011_0131)
10011985 (MedDRA 14.1)
MTHU021397 (LOINC Version 232)
L89 (ICD-10-CM Version 2010)
707.00 (ICD-9-CM Version 2011)
C0030486 (UMLS CUI 2011AA)
60389000 (SNOMED CT 2011_0131)
10033892 (MedDRA 14.1)
MTHU020806 (LOINC Version 232)
G82.20 (ICD-10-CM Version 2010)
344.1 (ICD-9-CM Version 2011)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
Presence of at least 3 of the following signs or symptoms:
Item
Presence of at least 3 of the following signs or symptoms:
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Purulent drainage or discharge
Item
Purulent drainage or discharge
boolean
C0439665 (UMLS CUI 2011AA)
255316004 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0333274 (UMLS CUI 2011AA)
35013009 (SNOMED CT 2011_0131)
10037569 (MedDRA 14.1)
Erythema extending > 1 cm from the wound edge
Item
Erythema extending > 1 cm from the wound edge
boolean
C0041834 (UMLS CUI 2011AA)
70819003 (SNOMED CT 2011_0131)
10015150 (MedDRA 14.1)
L53.9 (ICD-10-CM Version 2010)
695.9 (ICD-9-CM Version 2011)
C0439792 (UMLS CUI 2011AA)
260858005 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0475210 (UMLS CUI 2011AA)
258672001 (SNOMED CT 2011_0131)
C0043250 (UMLS CUI 2011AA)
13924000 (SNOMED CT 2011_0131)
10052428 (MedDRA 14.1)
MTHU001326 (LOINC Version 232)
C0205154 (UMLS CUI 2011AA)
57183005 (SNOMED CT 2011_0131)
Fluctuance
Item
Fluctuance
boolean
C0949036 (UMLS CUI 2011AA)
10051723 (MedDRA 14.1)
Pain or tenderness to palpation
Item
Pain or tenderness to palpation
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C0234233 (UMLS CUI 2011AA)
247348008 (SNOMED CT 2011_0131)
10043224 (MedDRA 14.1)
C0030247 (UMLS CUI 2011AA)
113011001 (SNOMED CT 2011_0131)
Swelling or induration
Item
Swelling or induration
boolean
C0038999 (UMLS CUI 2011AA)
442672001 (SNOMED CT 2011_0131)
10042674 (MedDRA 14.1)
C0332534 (UMLS CUI 2011AA)
45147008 (SNOMED CT 2011_0131)
10060708 (MedDRA 14.1)
Fever, defined as body temperature
Item
Fever, defined as body temperature
boolean
C0015967 (UMLS CUI 2011AA)
386661006 (SNOMED CT 2011_0131)
10005911 (MedDRA 14.1)
MTHU013518 (LOINC Version 232)
R50.9 (ICD-10-CM Version 2010)
780.60 (ICD-9-CM Version 2011)
E11102 (CTCAE 1105E)
C1704788 (UMLS CUI 2011AA)
C0005903 (UMLS CUI 2011AA)
386725007 (SNOMED CT 2011_0131)
MTHU001362 (LOINC Version 232)
> 37.5°C (axillary)
Item
> 37.5°C (axillary)
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
CL317948 (UMLS CUI 2011AA)
> 38°C (orally)
Item
> 38°C (orally)
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
> 38.5°C (tympanically) or
Item
> 38.5°C (tympanically) or
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
C0041445 (UMLS CUI 2011AA)
42859004 (SNOMED CT 2011_0131)
MTHU014731 (LOINC Version 232)
> 39°C (rectally)
Item
> 39°C (rectally)
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
C0205052 (UMLS CUI 2011AA)
255582007 (SNOMED CT 2011_0131)
OR
Item
Or
boolean
CL414906 (UMLS CUI 2011AA)
Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or
Item
Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or
boolean
CL414623 (UMLS CUI 2011AA)
C0205100 (UMLS CUI 2011AA)
14414005 (SNOMED CT 2011_0131)
C1271681 (UMLS CUI 2011AA)
391558003 (SNOMED CT 2011_0131)
10060297 (MedDRA 14.1)
>15 % immature neutrophils (bands) regardless of total peripheral WBC count
Item
>15 % immature neutrophils (bands) regardless of total peripheral WBC count
boolean
CL429329 (UMLS CUI 2011AA)
C0432611 (UMLS CUI 2011AA)
259712009 (SNOMED CT 2011_0131)
C1554079 (UMLS CUI 2011AA)
I (HL7 V3 2006_05)
C0205100 (UMLS CUI 2011AA)
14414005 (SNOMED CT 2011_0131)
C1271681 (UMLS CUI 2011AA)
391558003 (SNOMED CT 2011_0131)
10060297 (MedDRA 14.1)
C reactive protein (CRP) >20 mg/L
Item
C-Reactive Protein Measurement
boolean
C0201657 (UMLS CUI 2011AA)
55235003 (SNOMED CT 2011_0131)
10006824 (MedDRA 14.1)
Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
Item
Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
boolean
C0370003 (UMLS CUI 2011AA)
123038009 (SNOMED CT 2011_0131)
MTHU010726 (LOINC Version 232)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0430400 (UMLS CUI 2011AA)
252398009 (SNOMED CT 2011_0131)
10061447 (MedDRA 14.1)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
CL419348 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0439665 (UMLS CUI 2011AA)
255316004 (SNOMED CT 2011_0131)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0010468 (UMLS CUI 2011AA)
68688001 (SNOMED CT 2011_0131)
C0205148 (UMLS CUI 2011AA)
410679008 (SNOMED CT 2011_0131)
MTHU014970 (LOINC Version 232)
C0041582 (UMLS CUI 2011AA)
10045285 (SNOMED CT 2011_0131)
10045285 (MedDRA 14.1)
MTHU022920 (LOINC Version 232)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1704686 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
Item
Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
boolean
C0444921 (UMLS CUI 2011AA)
261773006 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0679106 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205453 (UMLS CUI 2011AA)
65607009 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
Item
Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
boolean
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0011079 (UMLS CUI 2011AA)
36777000 (SNOMED CT 2011_0131)
10067806 (MedDRA 14.1)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0750557 (UMLS CUI 2011AA)
C1555447 (UMLS CUI 2011AA)
MEDNEC (HL7 V3 2006_05)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1704686 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)
Item
Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0430056 (UMLS CUI 2011AA)
167252002 (SNOMED CT 2011_0131)
10036576 (MedDRA 14.1)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
The following skin and skin structure infections:
Item
The following skin and skin structure infections:
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
Item
Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
boolean
C0238124 (UMLS CUI 2011AA)
52486002 (SNOMED CT 2011_0131)
10028885 (MedDRA 14.1)
M72.6 (ICD-10-CM Version 2010)
728.86 (ICD-9-CM Version 2011)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0238419 (UMLS CUI 2011AA)
398318005 (SNOMED CT 2011_0131)
10017068 (MedDRA 14.1)
N49.3 (ICD-10-CM Version 2010)
C0276085 (UMLS CUI 2011AA)
17732003 (SNOMED CT 2011_0131)
10069756 (MedDRA 14.1)
C0854084 (UMLS CUI 2011AA)
10028888 (MedDRA 14.1)
C1622996 (UMLS CUI 2011AA)
413861006 (SNOMED CT 2011_0131)
C0238124 (UMLS CUI 2011AA)
52486002 (SNOMED CT 2011_0131)
10028885 (MedDRA 14.1)
M72.6 (ICD-10-CM Version 2010)
728.86 (ICD-9-CM Version 2011)
Burn wound infections
Item
Burn wound infections
boolean
C0006434 (UMLS CUI 2011AA)
48333001 (SNOMED CT 2011_0131)
10006634 (MedDRA 14.1)
MTHU007829 (LOINC Version 232)
T30.0 (ICD-10-CM Version 2010)
949.0 (ICD-9-CM Version 2011)
E11669 (CTCAE 1105E)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
Item
Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
boolean
C0442886 (UMLS CUI 2011AA)
264569006 (SNOMED CT 2011_0131)
10062158 (MedDRA 14.1)
C1290009 (UMLS CUI 2011AA)
128236002 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included
Item
Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0444752 (UMLS CUI 2011AA)
261389007 (SNOMED CT 2011_0131)
C0278403 (UMLS CUI 2011AA)
71966008 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C1145640 (UMLS CUI 2011AA)
52124006 (SNOMED CT 2011_0131)
C1828453 (UMLS CUI 2011AA)
424921004 (SNOMED CT 2011_0131)
CL381593 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0175649 (UMLS CUI 2011AA)
53350007 (SNOMED CT 2011_0131)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Infections where a surgical procedure alone is definitive therapy
Item
Infections where a surgical procedure alone is definitive therapy
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
CL426229 (UMLS CUI 2011AA)
Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
Item
Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
boolean
C0443334 (UMLS CUI 2011AA)
263914008 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0016436 (UMLS CUI 2011AA)
13600006 (SNOMED CT 2011_0131)
10016936 (MedDRA 14.1)
C0016867 (UMLS CUI 2011AA)
112650006 (SNOMED CT 2011_0131)
10017557 (MedDRA 14.1)
L02.92 (ICD-10-CM Version 2010)
C0007078 (UMLS CUI 2011AA)
41570003 (SNOMED CT 2011_0131)
10007247 (MedDRA 14.1)
C0205352 (UMLS CUI 2011AA)
13673007 (SNOMED CT 2011_0131)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0205124 (UMLS CUI 2011AA)
26283006 (SNOMED CT 2011_0131)
C0007642 (UMLS CUI 2011AA)
128045006 (SNOMED CT 2011_0131)
10007882 (MedDRA 14.1)
L03.90 (ICD-10-CM Version 2010)
Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
Item
Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0034428 (UMLS CUI 2011AA)
CL407060 (UMLS CUI 2011AA)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0026458 (UMLS CUI 2011AA)
90614001 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
Item
Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0268317 (UMLS CUI 2011AA)
75066002 (SNOMED CT 2011_0131)
C0920027 (UMLS CUI 2011AA)
10050279 (MedDRA 14.1)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
CL414314 (UMLS CUI 2011AA)
89519005 (SNOMED CT 2011_0131)
MTHU006777 (LOINC Version 232)
Severe, life threatening disease with a life expectancy of < 2 months
Item
Severe, life threatening disease with a life expectancy of < 2 months
boolean
C2711184 (UMLS CUI 2011AA)
442452003 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Immunosuppression including:
Item
Immunosuppression including:
boolean
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
Known neutropenia (neutrophil count < 1000/µL)
Item
Known neutropenia (neutrophil count < 1000/µL)
boolean
C0853697 (UMLS CUI 2011AA)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
Known lymphopenia with absolute CD4+ T cell count < 200/mm3
Item
Known lymphopenia with absolute CD4+ T cell count < 200/mm3
boolean
C0024312 (UMLS CUI 2011AA)
48813009 (SNOMED CT 2011_0131)
10025327 (MedDRA 14.1)
D72.810 (ICD-10-CM Version 2010)
288.51 (ICD-9-CM Version 2011)
E12190 (CTCAE 1105E)
C0243009 (UMLS CUI 2011AA)
MTHU112269 (CTCAE 1105E)
Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
Item
Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
boolean
C0001175 (UMLS CUI 2011AA)
62479008 (SNOMED CT 2011_0131)
10000565 (MedDRA 14.1)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C1707479 (UMLS CUI 2011AA)
C0887947 (UMLS CUI 2011AA)
416234007 (SNOMED CT 2011_0131)
Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
Item
Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Any other congenital or acquired immune defect or immunosuppression
Item
Any other congenital or acquired immune defect or immunosuppression
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0009678 (UMLS CUI 2011AA)
C0439661 (UMLS CUI 2011AA)
255396000 (SNOMED CT 2011_0131)
C0021053 (UMLS CUI 2011AA)
71922006 (SNOMED CT 2011_0131)
10021425 (MedDRA 14.1)
D89.9 (ICD-10-CM Version 2010)
279.9 (ICD-9-CM Version 2011)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
Item
Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
C4050412 (UMLS CUI 2011AA)
C0439106 (UMLS CUI 2011AA)
257962003 (SNOMED CT 2011_0131)
C0438717 (UMLS CUI 2011AA)
10054889 (MedDRA 14.1)
CL384738 (UMLS CUI 2011AA)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C1632851 (UMLS CUI 2011AA)
417929005 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
Item
Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
boolean
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C1442488 (UMLS CUI 2011AA)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
Item
Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
boolean
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
C2347852 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C1287082 (UMLS CUI 2011AA)
365417009 (SNOMED CT 2011_0131)
C1579436 (UMLS CUI 2011AA)
C0360703 (UMLS CUI 2011AA)
372855004 (SNOMED CT 2011_0131)
C0034414 (UMLS CUI 2011AA)
372697008 (SNOMED CT 2011_0131)
MTHU005039 (LOINC Version 232)
C0033216 (UMLS CUI 2011AA)
372589008 (SNOMED CT 2011_0131)
MTHU005035 (LOINC Version 232)
C0002598 (UMLS CUI 2011AA)
372821002 (SNOMED CT 2011_0131)
MTHU004841 (LOINC Version 232)
C0037707 (UMLS CUI 2011AA)
372911006 (SNOMED CT 2011_0131)
MTHU003385 (LOINC Version 232)
C0040615 (UMLS CUI 2011AA)
10784006, 372482001 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
C0018546 (UMLS CUI 2011AA)
386837002 (SNOMED CT 2011_0131)
MTHU005005 (LOINC Version 232)
C0003290 (UMLS CUI 2011AA)
373253007 (SNOMED CT 2011_0131)
MTHU001920 (LOINC Version 232)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C0030863 (UMLS CUI 2011AA)
372699006 (SNOMED CT 2011_0131)
C0120726 (UMLS CUI 2011AA)
372527008 (SNOMED CT 2011_0131)
C0019590 (UMLS CUI 2011AA)
372806008 (SNOMED CT 2011_0131)
MTHU003328 (LOINC Version 232)
C0085173 (UMLS CUI 2011AA)
387089004 (SNOMED CT 2011_0131)
MTHU003387 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0072916 (UMLS CUI 2011AA)
387164008 (SNOMED CT 2011_0131)
MTHU012783 (LOINC Version 232)
C0042674 (UMLS CUI 2011AA)
C0677510 (UMLS CUI 2011AA)
260317009 (SNOMED CT 2011_0131)
C0301371 (UMLS CUI 2011AA)
373748003 (SNOMED CT 2011_0131)
Uncorrected hypokalemia
Item
Uncorrected hypokalemia
boolean
C1518422 (UMLS CUI 2011AA)
C1947976 (UMLS CUI 2011AA)
C0020621 (UMLS CUI 2011AA)
43339004 (SNOMED CT 2011_0131)
10021015 (MedDRA 14.1)
E87.6 (ICD-10-CM Version 2010)
276.8 (ICD-9-CM Version 2011)
E12327 (CTCAE 1105E)
Clinically relevant bradycardia
Item
Clinically relevant bradycardia
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0428977 (UMLS CUI 2011AA)
48867003 (SNOMED CT 2011_0131)
10006093 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
Item
Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1096403 (UMLS CUI 2011AA)
10053222 (MedDRA 14.1)
CL384716 (UMLS CUI 2011AA)
Previous history of symptomatic arrhythmias
Item
Previous history of symptomatic arrhythmias
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Previous history of tendon disease/disorder with quinolones
Item
Previous history of tendon disease/disorder with quinolones
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0151936 (UMLS CUI 2011AA)
68172002 (SNOMED CT 2011_0131)
10043239 (MedDRA 14.1)
C0034428 (UMLS CUI 2011AA)
Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
Item
Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0854606 (UMLS CUI 2011AA)
10042933 (MedDRA 14.1)
C1692886 (UMLS CUI 2011AA)
372938004 (SNOMED CT 2011_0131)
10053555 (MedDRA 14.1)
M00.9 (ICD-10-CM Version 2010)
711.0 (ICD-9-CM Version 2011)
Requiring therapy with probenecid
Item
Requiring therapy with probenecid
boolean
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0033209 (UMLS CUI 2011AA)
387365004 (SNOMED CT 2011_0131)
MTHU007603 (LOINC Version 232)
Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
Item
Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
boolean
C0039798 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0279516 (UMLS CUI 2011AA)
419241000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205453 (UMLS CUI 2011AA)
65607009 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
C0332271 (UMLS CUI 2011AA)
230993007 (SNOMED CT 2011_0131)
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C1514463 (UMLS CUI 2011AA)
C0430400 (UMLS CUI 2011AA)
252398009 (SNOMED CT 2011_0131)
10061447 (MedDRA 14.1)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0546816 (UMLS CUI 2011AA)
130965009 (SNOMED CT 2011_0131)
C0450254 (UMLS CUI 2011AA)
264418008 (SNOMED CT 2011_0131)
C0231204 (UMLS CUI 2011AA)
131196009 (SNOMED CT 2011_0131)
S (HL7 V3 2006_05)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0949665 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0282215 (UMLS CUI 2011AA)
406778007 (SNOMED CT 2011_0131)
C0597979 (UMLS CUI 2011AA)
79744009 (SNOMED CT 2011_0131)
Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
Item
Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
boolean
C0343401 (UMLS CUI 2011AA)
266096002 (SNOMED CT 2011_0131)
10027508 (MedDRA 14.1)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C1955827 (UMLS CUI 2011AA)
C0038174 (UMLS CUI 2011AA)
60875001 (SNOMED CT 2011_0131)
C1265175 (UMLS CUI 2011AA)
113727004 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0205409 (UMLS CUI 2011AA)
46651001 (SNOMED CT 2011_0131)
C0450254 (UMLS CUI 2011AA)
264418008 (SNOMED CT 2011_0131)
Previous enrolment in this study
Item
Previous enrolment in this study
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Participation in any clinical investigational drug study within 4 weeks of screening
Item
Participation in any clinical investigational drug study within 4 weeks of screening
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Previous history of seizure disorders
Item
Previous history of seizure disorders
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)

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