Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
Age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Severe sepsis or septic shock according to ACCP/SCCM criteria
Item
Severe sepsis or septic shock according to ACCP/SCCM criteria
boolean
C1719672 (UMLS CUI 2011AA)
R65.2 (ICD-10-CM Version 2010)
995.92 (ICD-9-CM Version 2011)
C0036983 (UMLS CUI 2011AA)
76571007 (SNOMED CT 2011_0131)
10040070 (MedDRA 14.1)
785.52 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1706462 (UMLS CUI 2011AA)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0586857 (UMLS CUI 2011AA)
309345004 (SNOMED CT 2011_0131)
C0037459 (UMLS CUI 2011AA)
C1319411 (UMLS CUI 2011AA)
408478003 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Onset of severe sepsis or septic shock <24 h
Item
Onset of severe sepsis or septic shock <24 h
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C1719672 (UMLS CUI 2011AA)
R65.2 (ICD-10-CM Version 2010)
995.92 (ICD-9-CM Version 2011)
C0036983 (UMLS CUI 2011AA)
76571007 (SNOMED CT 2011_0131)
10040070 (MedDRA 14.1)
785.52 (ICD-9-CM Version 2011)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Informed consent
Item
Einverständniserklärung
boolean
C0021430 (UMLS CUI 2011AA)
Effective contraception in fertile women
Item
Effective contraception in fertile women
boolean
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL426012 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Age <18 years
Item
Alter <18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pregnancy
Item
Schwangerschaft
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Breast-feeding women
Item
Stillzeit
boolean
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (>1 daily dosage)
Item
Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (>1 daily dosage)
boolean
C1514463 (UMLS CUI 2011AA)
C0066005 (UMLS CUI 2011AA)
387540000 (SNOMED CT 2011_0131)
MTHU008102 (LOINC Version 232)
C0020933 (UMLS CUI 2011AA)
46558003 (SNOMED CT 2011_0131)
MTHU007072 (LOINC Version 232)
C1120106 (UMLS CUI 2011AA)
396346003 (SNOMED CT 2011_0131)
MTHU016193 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (>1 daily dosage)
Item
Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (>1 daily dosage)
boolean
C1514463 (UMLS CUI 2011AA)
C0536495 (UMLS CUI 2011AA)
412439003 (SNOMED CT 2011_0131)
MTHU014635 (LOINC Version 232)
C0008809 (UMLS CUI 2011AA)
372840008 (SNOMED CT 2011_0131)
MTHU004599 (LOINC Version 232)
C0282386 (UMLS CUI 2011AA)
387552007 (SNOMED CT 2011_0131)
MTHU009097 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (>1 daily dosage).
Item
Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (>1 daily dosage).
boolean
C1514463 (UMLS CUI 2011AA)
C0033808 (UMLS CUI 2011AA)
57032008 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C2266959 (UMLS CUI 2011AA)
373262009 (SNOMED CT 2011_0131)
C0055003 (UMLS CUI 2011AA)
96048006 (SNOMED CT 2011_0131)
MTHU008443 (LOINC Version 232)
C0007559 (UMLS CUI 2011AA)
387200005 (SNOMED CT 2011_0131)
MTHU003920 (LOINC Version 232)
C0062986 (UMLS CUI 2011AA)
387533001 (SNOMED CT 2011_0131)
MTHU008447 (LOINC Version 232)
C0031955 (UMLS CUI 2011AA)
372836004 (SNOMED CT 2011_0131)
MTHU008471 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Pretreatment with other chinolones within the last 4 weeks (>1 daily dosage)
Item
Pretreatment with other chinolones within the last 4 weeks (>1 daily dosage)
boolean
C1514463 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0034428 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2348070 (UMLS CUI 2011AA)
Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)
Item
Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0220845 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0338237 (UMLS CUI 2011AA)
281789004 (SNOMED CT 2011_0131)
10067768 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0014118 (UMLS CUI 2011AA)
56819008 (SNOMED CT 2011_0131)
10014665 (MedDRA 14.1)
424.90 (ICD-9-CM Version 2011)
Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)
Item
Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0442821 (UMLS CUI 2011AA)
260404005 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0242114 (UMLS CUI 2011AA)
C0445623 (UMLS CUI 2011AA)
264395009 (SNOMED CT 2011_0131)
MTHU019420 (LOINC Version 232)
MIC (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
C0343401 (UMLS CUI 2011AA)
266096002 (SNOMED CT 2011_0131)
10021839 (MedDRA 14.1)
041.12 (ICD-9-CM Version 2011)
C1265175 (UMLS CUI 2011AA)
113727004 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Known allergy against meropenem or moxifloxacin
Item
Known allergy against meropenem or moxifloxacin
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0066005 (UMLS CUI 2011AA)
387540000 (SNOMED CT 2011_0131)
MTHU008102 (LOINC Version 232)
C0536495 (UMLS CUI 2011AA)
412439003 (SNOMED CT 2011_0131)
MTHU014635 (LOINC Version 232)
Tendon disease or injury due to past quinolone therapy
Item
Tendon disease or injury due to past quinolone therapy
boolean
C0039504 (UMLS CUI 2011AA)
240037007 (SNOMED CT 2011_0131)
10043242 (MedDRA 14.1)
C1280538 (UMLS CUI 2011AA)
256667004 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0034428 (UMLS CUI 2011AA)
Congenital or acquired prolongation of QT-interval
Item
Congenital or acquired prolongation of QT-interval
boolean
C0009678 (UMLS CUI 2011AA)
C0439661 (UMLS CUI 2011AA)
255396000 (SNOMED CT 2011_0131)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
Concomitant medication which prolongs the QT-interval
Item
Concomitant medication which prolongs the QT-interval
boolean
C2347852 (UMLS CUI 2011AA)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
Electrolyte imbalance, especially uncorrected hypokalemia
Item
Electrolyte imbalance, especially uncorrected hypokalemia
boolean
CL354536 (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)
C1518422 (UMLS CUI 2011AA)
C1947976 (UMLS CUI 2011AA)
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 cardiac dysfunction with reduced left-ventricular ejection fraction
Item
Clinically relevant cardiac dysfunction with reduced left-ventricular ejection fraction
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C1096403 (UMLS CUI 2011AA)
10053222 (MedDRA 14.1)
Symptomatic arrhythmias in the medical history
Item
Symptomatic arrhythmias in the medical history
boolean
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)
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes >5x the upper normal range
Item
Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes >5x the upper normal range
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0948807 (UMLS CUI 2011AA)
10052254 (MedDRA 14.1)
C2347612 (UMLS CUI 2011AA)
C0857093 (UMLS CUI 2011AA)
10014480 (MedDRA 14.1)
CL384738 (UMLS CUI 2011AA)
C0086715 (UMLS CUI 2011AA)
260395002 (SNOMED CT 2011_0131)
No commitment to full patient support (i.e. DNR order)
Item
No commitment to full patient support (i.e. DNR order)
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0026528 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1521721 (UMLS CUI 2011AA)
C0079252 (UMLS CUI 2011AA)
Patient's death is considered imminent due to coexisting disease
Item
Patient's death is considered imminent due to coexisting disease
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C2363727 (UMLS CUI 2011AA)
10068311 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0243087 (UMLS CUI 2011AA)
Concomitant participation in another study or study participation within the last 30 days.
Item
Concomitant participation in another study or study participation within the last 30 days.
boolean
CL415222 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Relationship of the patient to study team member (i.e. colleague, relative)
Item
Relationship of the patient to study team member (i.e. colleague, relative)
boolean
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1552089 (UMLS CUI 2011AA)
STF (HL7 V3 2006_05)
C0080103 (UMLS CUI 2011AA)
125677006 (SNOMED CT 2011_0131)
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