ID

35461

Beskrivning

Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Culture results form. It has to be filled for each Visit (1-5).

Länk

https://clinicaltrials.gov/ct2/show/NCT00852540

Nyckelord

  1. 2019-03-04 2019-03-04 -
  2. 2019-03-11 2019-03-11 -
  3. 2019-03-12 2019-03-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 mars 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

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Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540

Culture results

  1. StudyEvent: ODM
    1. Culture results
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beskrivning

Visit type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Nasal Swab Sample
Beskrivning

Nasal Swab Sample

Alias
UMLS CUI-1
C3669207
Was a sample taken?
Beskrivning

Nasal Swab Sample

Datatyp

text

Alias
UMLS CUI [1]
C3669207
Date of sample
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3669207
If there was no sample taken, please specify reason
Beskrivning

Reason, no sample taken

Datatyp

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C3669207
If other reason, please specify
Beskrivning

Other reason, no sample taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1298908
UMLS CUI [1,4]
C3669207
Culture Results for Nasal Swab
Beskrivning

Culture Results for Nasal Swab

Alias
UMLS CUI-1
C3669207
UMLS CUI-2
C1274040
Lab test date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826247
Lab test time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1]
C0429928
Was there any growth after 2 days?
Beskrivning

Growth of culture

Datatyp

text

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C3669207
Growth of culture, specification
Beskrivning

Normal flora: includes coagulase-negative staphylococci, Viridans streptococci, Corynebacterium species, Non-pathogenic Neisseria species, Stomatococcus species, Micrococcus species, non-haemolytic Streptococcus species)

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0018284
UMLS CUI [1,3]
C3669207
Isolate Detail for Nasal Swab
Beskrivning

Isolate Detail for Nasal Swab

Alias
UMLS CUI-1
C1764827
UMLS CUI-2
C3669207
Isolate number
Beskrivning

Isolate number

Datatyp

text

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0237753
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Semiquantitation/ growth estimate
Beskrivning

Semiquantitation/ growth estimate

Datatyp

integer

Alias
UMLS CUI [1]
C0018284
Identification of microorganism
Beskrivning

Identification of microorganism

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C0596932
If other identification of microorganism, please specify
Beskrivning

Other identification of microorganism

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0596932
Was Staphylococcus aureus recovered?
Beskrivning

Recovering of Staphylococcus aureus

Datatyp

integer

Alias
UMLS CUI [1]
C0038172
If Staphylococcus aureus recovered, isolate(s) not sent to central laboratory, please specify reason
Beskrivning

Staphylococcus aureus recovered, isolate(s) not sent to central laboratory, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0038172
UMLS CUI [1,2]
C1880016
UMLS CUI [1,3]
C1515023
UMLS CUI [1,4]
C1272696
UMLS CUI [1,5]
C0566251
Wound/Lesion specimen - bacteriology
Beskrivning

Wound/Lesion specimen - bacteriology

Alias
UMLS CUI-1
C0043241
UMLS CUI-2
C0004644
Was a sample taken?
Beskrivning

Sample taken

Datatyp

text

Alias
UMLS CUI [1]
C0200345
Date of sample
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3669207
If there was no sample taken, please specify reason
Beskrivning

Reason, no sample taken

Datatyp

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C3669207
If other reason, please specify
Beskrivning

Other reason, no sample taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1298908
UMLS CUI [1,4]
C3669207
Specimen collection method
Beskrivning

Specimen collection method

Datatyp

integer

Alias
UMLS CUI [1]
C1547864
Reason for selecting skin swab collection method
Beskrivning

Reason for selecting skin swab collection method

Datatyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C1261188
UMLS CUI [1,4]
C1547864
Gram Stain Results for Wound/Lesion Bacteriology Specimen
Beskrivning

Gram Stain Results for Wound/Lesion Bacteriology Specimen

Alias
UMLS CUI-1
C0061856
UMLS CUI-2
C1274040
UMLS CUI-3
C0004644
Lab test date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2826247
Lab test time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0429928
White Blood Cells (per 100x LPF)
Beskrivning

White Blood Cells

Datatyp

integer

Alias
UMLS CUI [1]
C0023508
Epithelial Cells (per 100x LPF)
Beskrivning

Epithelial Cells

Datatyp

integer

Alias
UMLS CUI [1]
C1273342
Bacteria (per 1000x) in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample
Beskrivning

Bacteria in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample

Datatyp

integer

Alias
UMLS CUI [1,1]
C0004611
UMLS CUI [1,2]
C1123023
UMLS CUI [1,3]
C0010468
UMLS CUI [2,1]
C0004611
UMLS CUI [2,2]
C0349707
UMLS CUI [3,1]
C0004611
UMLS CUI [3,2]
C1123023
UMLS CUI [3,3]
C1261188
UMLS CUI [3,4]
C0681875
Bacteria (per 1000x) in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample
Beskrivning

Results of Bacteria

Datatyp

integer

Alias
UMLS CUI [1,1]
C0004611
UMLS CUI [1,2]
C1254595
Culture results for skin curettage
Beskrivning

Culture results for skin curettage

Alias
UMLS CUI-1
C1123023
UMLS CUI-2
C0010468
UMLS CUI-3
C1254595
Was there any growth after 2 days?
Beskrivning

Growth of culture

Datatyp

text

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C0018284
If there was a growth, please specify
Beskrivning

Normal skin flora: includes coagulase negative staphylococci, alpha-haemolytic Streptococcus species (not Group D), Corynebacterium species, Micrococcus species)

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C2348235
Isolate Detail for Skin Curettage
Beskrivning

Isolate Detail for Skin Curettage

Alias
UMLS CUI-1
C1764827
UMLS CUI-2
C1123023
UMLS CUI-3
C0010468
Isolate number
Beskrivning

Isolate number

Datatyp

text

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0237753
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Semiquantitation/ growth estimate
Beskrivning

Semiquantitation/ growth estimate

Datatyp

integer

Alias
UMLS CUI [1]
C0018284
Identification of microorganism
Beskrivning

Identification of microorganism

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C0596932
If other identification of microorganism, please specify
Beskrivning

Other identification of microorganism

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0596932
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
Beskrivning

Isolate(s) sent to central laboratory

Datatyp

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If isolate(s) not sent to central laboratory, please specify reason
Beskrivning

Isolate(s) not sent to central laboratory, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0566251
Culture results for aseptic needle aspirate
Beskrivning

Culture results for aseptic needle aspirate

Alias
UMLS CUI-1
C0430400
UMLS CUI-2
C1274040
UMLS CUI-3
C0232920
UMLS CUI-4
C0936232
UMLS CUI-5
C0370199
Was there any growth after 3 days?
Beskrivning

Growth of culture

Datatyp

text

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C0018284
If there was a growth, please specify
Beskrivning

Normal skin flora: includes coagulase negative staphylococci, alpha-haemolytic Streptococcus species (not Group D), Corynebacterium species, Micrococcus species)

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C2348235
If normal flora was isolated, were any of the organisms isolated in pure culture?
Beskrivning

Isolation of organism in pure culture

Datatyp

text

Alias
UMLS CUI [1,1]
C0205409
UMLS CUI [1,2]
C0596932
If organisms was isolated in pure culture, select organism
Beskrivning

Organism selection

Datatyp

integer

Alias
UMLS CUI [1,1]
C0029235
UMLS CUI [1,2]
C0681875
Isolate Detail for aseptic needle aspirate
Beskrivning

Isolate Detail for aseptic needle aspirate

Alias
UMLS CUI-1
C1764827
UMLS CUI-2
C0232920
UMLS CUI-3
C0370199
Isolate number
Beskrivning

Isolate number

Datatyp

text

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0237753
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Semiquantitation/ growth estimate
Beskrivning

Semiquantitation/ growth estimate

Datatyp

integer

Alias
UMLS CUI [1]
C0018284
Identification of microorganism
Beskrivning

Identification of microorganism

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C0596932
If other identification of microorganism, please specify
Beskrivning

Other identification of microorganism

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0596932
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
Beskrivning

Isolate(s) sent to central laboratory

Datatyp

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If isolate(s) not sent to central laboratory, please specify reason
Beskrivning

Isolate(s) not sent to central laboratory, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0566251
Culture results for skin swab
Beskrivning

Culture results for skin swab

Alias
UMLS CUI-1
C1123023
UMLS CUI-2
C1261188
UMLS CUI-3
C1254595
Was there any growth after 2 days?
Beskrivning

Growth of culture

Datatyp

text

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C0018284
If there was a growth, please specify
Beskrivning

Normal skin flora: includes coagulase negative staphylococci, alpha-haemolytic Streptococcus species (not Group D), Corynebacterium species, Micrococcus species)

Datatyp

integer

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C2348235
Isolate Detail for Skin Swab
Beskrivning

Isolate Detail for Skin Swab

Alias
UMLS CUI-1
C1764827
UMLS CUI-2
C1123023
UMLS CUI-3
C1261188
Isolate number
Beskrivning

Isolate number

Datatyp

text

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0237753
Visit Type
Beskrivning

Visit Type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Semiquantitation/ growth estimate
Beskrivning

Semiquantitation/ growth estimate

Datatyp

integer

Alias
UMLS CUI [1]
C0018284
Identification of microorganism
Beskrivning

Identification of microorganism

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C0596932
If other identification of microorganism, please specify
Beskrivning

Other identification of microorganism

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205396
UMLS CUI [1,3]
C0596932
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
Beskrivning

Isolate(s) sent to central laboratory

Datatyp

text

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1880016
If isolate(s) not sent to central laboratory, please specify reason
Beskrivning

Isolate(s) not sent to central laboratory, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0566251

Similar models

Culture results

  1. StudyEvent: ODM
    1. Culture results
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Item Group
Nasal Swab Sample
C3669207 (UMLS CUI-1)
Item
Was a sample taken?
text
C3669207 (UMLS CUI [1])
Code List
Was a sample taken?
CL Item
Yes (Y)
CL Item
No (N)
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C3669207 (UMLS CUI [1,2])
Item
If there was no sample taken, please specify reason
integer
C0566251 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C3669207 (UMLS CUI [1,3])
Code List
If there was no sample taken, please specify reason
CL Item
Patient Refused (1)
CL Item
Parent/legal guardian refused (2)
CL Item
Patient exceptionally uncooperative (3)
CL Item
Investigator deemed inappropriate/unnecessary (4)
CL Item
Other (5)
Other reason, no sample taken
Item
If other reason, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C3669207 (UMLS CUI [1,4])
Item Group
Culture Results for Nasal Swab
C3669207 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Lab test date
Item
Lab test date
date
C2826247 (UMLS CUI [1])
Lab test time
Item
Lab test time
time
C0429928 (UMLS CUI [1])
Item
Was there any growth after 2 days?
text
C0018284 (UMLS CUI [1,1])
C3669207 (UMLS CUI [1,2])
Code List
Was there any growth after 2 days?
CL Item
No (N)
CL Item
Yes (Y)
Item
Growth of culture, specification
integer
C2348235 (UMLS CUI [1,1])
C0018284 (UMLS CUI [1,2])
C3669207 (UMLS CUI [1,3])
Code List
Growth of culture, specification
CL Item
Normal flora (1)
CL Item
Candida species, other yeast or mould (2)
CL Item
Pathogen isolated for culture (3)
Item Group
Isolate Detail for Nasal Swab
C1764827 (UMLS CUI-1)
C3669207 (UMLS CUI-2)
Isolate number
Item
Isolate number
text
C1764827 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Item
Semiquantitation/ growth estimate
integer
C0018284 (UMLS CUI [1])
Code List
Semiquantitation/ growth estimate
CL Item
1+ (1)
CL Item
2+ (2)
CL Item
3+ (3)
CL Item
4+ (4)
Item
Identification of microorganism
integer
C0205396 (UMLS CUI [1,1])
C0596932 (UMLS CUI [1,2])
Code List
Identification of microorganism
CL Item
Acinetobacter anitratus  (1)
CL Item
Acinetobacter calcoaceticus  (2)
CL Item
Acinetobacter lwoffi  (3)
CL Item
Acinetobacter species  (4)
CL Item
Bacillus species  (5)
CL Item
Beta haemolytic streptococcus - non-groupable  (6)
CL Item
Beta haemolytic streptococcus group A  (7)
CL Item
Beta haemolytic streptococcus group B  (8)
CL Item
Beta haemolytic streptococcus group C  (9)
CL Item
Beta haemolytic streptococcus group D  (10)
CL Item
Beta haemolytic streptococcus group D not Enterococcus  (11)
CL Item
Beta haemolytic streptococcus group F  (12)
CL Item
Beta haemolytic streptococcus group G  (13)
CL Item
Citrobacter diversus  (14)
CL Item
Citrobacter freundii  (15)
CL Item
Citrobacter species  (16)
CL Item
Enterobacter aerogenes  (17)
CL Item
Enterobacter agglomerans  (18)
CL Item
Enterobacter amnigenus  (19)
CL Item
Enterobacter cloacae  (20)
CL Item
Enterobacter gergoviae  (21)
CL Item
Enterobacter sakazakii  (22)
CL Item
Enterobacter species  (23)
CL Item
Enterobacteriaceae  (24)
CL Item
Enterococcus faecalis  (25)
CL Item
Enterococcus faecium  (26)
CL Item
Enterococcus species  (27)
CL Item
Escherichia coli  (28)
CL Item
Gram negative non-Enterobacteriaceae  (29)
CL Item
Haemophilus influenzae  (30)
CL Item
Haemophilus parainfluenzae  (31)
CL Item
Haemophilus species  (32)
CL Item
Klebsiella oxytoca  (33)
CL Item
Klebsiella pneumoniae  (34)
CL Item
Klebsiella species  (35)
CL Item
Mixed microbial flora  (36)
CL Item
Moraxella catarrhalis  (37)
CL Item
Moraxella species  (38)
CL Item
Morganella morganii  (39)
CL Item
Neisseria meningitidis  (40)
CL Item
Neisseria species  (41)
CL Item
Non-fermenting gram negative bacilli  (42)
CL Item
Oxidase positive gram negative rod  (43)
CL Item
Pantoea species  (44)
CL Item
Pasteurella haemolytica  (45)
CL Item
Pasteurella multocida  (46)
CL Item
Pasteurella species  (47)
CL Item
Proteus mirabilis  (48)
CL Item
Proteus penneri  (49)
CL Item
Proteus species  (50)
CL Item
Pseudomonas aeruginosa  (51)
CL Item
Pseudomonas alcaligenes  (52)
CL Item
Pseudomonas fluorescens  (53)
CL Item
Pseudomonas fluorescens/putida group  (54)
CL Item
Pseudomonas paucimobilis  (55)
CL Item
Pseudomonas species  (56)
CL Item
Pseudomonas stutzeri  (57)
CL Item
Pseudomonas vesicularis  (58)
CL Item
Ralstonia pickettii  (59)
CL Item
Serratia marcescens  (60)
CL Item
Serratia odorifera  (61)
CL Item
Serratia species  (62)
CL Item
Staphylococcus aureus  (63)
CL Item
Streptococcus agalactiae  (64)
CL Item
Streptococcus anginosis  (65)
CL Item
Streptococcus constellatus  (66)
CL Item
Streptococcus dysgalactiae  (67)
CL Item
Streptococcus dysgalactiae - equisimilis  (68)
CL Item
Streptococcus equisimilis  (69)
CL Item
Streptococcus intermedius  (70)
CL Item
Streptococcus pneumoniae  (71)
CL Item
Streptococcus pyogenes  (72)
CL Item
Streptococcus species  (73)
CL Item
Unidentified organism  (74)
CL Item
Other (75)
Other identification of microorganism
Item
If other identification of microorganism, please specify
text
C0205394 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
Item
Was Staphylococcus aureus recovered?
integer
C0038172 (UMLS CUI [1])
Code List
Was Staphylococcus aureus recovered?
CL Item
No, S. aureus not recovered (1)
CL Item
Yes, isolate(s) sent to the central laboratory (2)
CL Item
Staphylococcus aureus recovered, isolate(s) not sent to central laboratory (3)
Staphylococcus aureus recovered, isolate(s) not sent to central laboratory, Reason
Item
If Staphylococcus aureus recovered, isolate(s) not sent to central laboratory, please specify reason
text
C0038172 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Item Group
Wound/Lesion specimen - bacteriology
C0043241 (UMLS CUI-1)
C0004644 (UMLS CUI-2)
Item
Was a sample taken?
text
C0200345 (UMLS CUI [1])
Code List
Was a sample taken?
CL Item
Yes (Y)
CL Item
No (N)
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C3669207 (UMLS CUI [1,2])
Item
If there was no sample taken, please specify reason
integer
C0566251 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C3669207 (UMLS CUI [1,3])
Code List
If there was no sample taken, please specify reason
CL Item
No culturable material present (1)
CL Item
Parent/legal guardian refused (2)
CL Item
Patient exceptionally uncooperative (3)
CL Item
Patient Refused (4)
CL Item
Other (5)
Other reason, no sample taken
Item
If other reason, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C3669207 (UMLS CUI [1,4])
Item
Specimen collection method
integer
C1547864 (UMLS CUI [1])
Code List
Specimen collection method
CL Item
Skin curettage (1)
CL Item
Aseptic needle aspiration (2)
CL Item
Skin Swab (3)
Reason for selecting skin swab collection method
Item
Reason for selecting skin swab collection method
text
C0566251 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C1261188 (UMLS CUI [1,3])
C1547864 (UMLS CUI [1,4])
Item Group
Gram Stain Results for Wound/Lesion Bacteriology Specimen
C0061856 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0004644 (UMLS CUI-3)
Lab test date
Item
Lab test date
date
C0022885 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Lab test time
Item
Lab test time
time
C0022885 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
White Blood Cells (per 100x LPF)
integer
C0023508 (UMLS CUI [1])
Code List
White Blood Cells (per 100x LPF)
CL Item
0 or none  (1)
CL Item
1-9 or few  (2)
CL Item
10-24 or moderate  (3)
CL Item
>=25 or many (4)
Item
Epithelial Cells (per 100x LPF)
integer
C1273342 (UMLS CUI [1])
Code List
Epithelial Cells (per 100x LPF)
CL Item
0 or none  (1)
CL Item
1-9 or few  (2)
CL Item
10-24 or moderate  (3)
CL Item
>=25 or many (4)
Item
Bacteria (per 1000x) in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample
integer
C0004611 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
C0010468 (UMLS CUI [1,3])
C0004611 (UMLS CUI [2,1])
C0349707 (UMLS CUI [2,2])
C0004611 (UMLS CUI [3,1])
C1123023 (UMLS CUI [3,2])
C1261188 (UMLS CUI [3,3])
C0681875 (UMLS CUI [3,4])
Code List
Bacteria (per 1000x) in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample
CL Item
Gram positive bacilli (1)
CL Item
Gram negative diplococci (2)
CL Item
Gram positive diplococci (3)
CL Item
Gram positive cocci in clusters (4)
CL Item
Gram positive cocci in chains (5)
CL Item
Gram variable bacilli (6)
CL Item
Gram positive cocci in pairs (7)
CL Item
Gram negative bacilli (8)
CL Item
Gram negative cocci (9)
CL Item
Gram negative coccobacilli (10)
CL Item
Hyphal elements (11)
CL Item
Yeast (12)
Item
Bacteria (per 1000x) in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample
integer
C0004611 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Code List
Bacteria (per 1000x) in Skin Curettage/Aseptic Needle Aspiration/Skin Swab Sample
CL Item
0 or none  (1)
CL Item
1-4 or occasional  (2)
CL Item
5-9 or few  (3)
CL Item
10-50 or moderate  (4)
CL Item
>50 or many  (5)
CL Item
<1 or rare (6)
Item Group
Culture results for skin curettage
C1123023 (UMLS CUI-1)
C0010468 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Item
Was there any growth after 2 days?
text
C0430400 (UMLS CUI [1,1])
C0018284 (UMLS CUI [1,2])
Code List
Was there any growth after 2 days?
CL Item
No (no growth) (N)
CL Item
Yes (Y)
Item
If there was a growth, please specify
integer
C0018284 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If there was a growth, please specify
CL Item
Normal skin flora (1)
CL Item
Candida species, other yeast or mould (2)
CL Item
Pathogen isolated for culture (3)
Item Group
Isolate Detail for Skin Curettage
C1764827 (UMLS CUI-1)
C1123023 (UMLS CUI-2)
C0010468 (UMLS CUI-3)
Isolate number
Item
Isolate number
text
C1764827 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Item
Semiquantitation/ growth estimate
integer
C0018284 (UMLS CUI [1])
Code List
Semiquantitation/ growth estimate
CL Item
1+ (1)
CL Item
2+ (2)
CL Item
3+ (3)
CL Item
4+ (4)
Item
Identification of microorganism
integer
C0205396 (UMLS CUI [1,1])
C0596932 (UMLS CUI [1,2])
Code List
Identification of microorganism
CL Item
Acinetobacter anitratus  (1)
CL Item
Acinetobacter calcoaceticus  (2)
CL Item
Acinetobacter lwoffi  (3)
CL Item
Acinetobacter species  (4)
CL Item
Aeromonas species  (5)
CL Item
Aeromonas hydrophila  (6)
CL Item
Bacillus species  (7)
CL Item
Beta haemolytic streptococcus - non-groupable  (8)
CL Item
Beta haemolytic streptococcus group A  (9)
CL Item
Beta haemolytic streptococcus group B  (10)
CL Item
Beta haemolytic streptococcus group C  (11)
CL Item
Beta haemolytic streptococcus group D  (12)
CL Item
Beta haemolytic streptococcus group D not Enterococcus  (13)
CL Item
Beta haemolytic streptococcus group F  (14)
CL Item
Beta haemolytic streptococcus group G  (15)
CL Item
Citrobacter diversus  (16)
CL Item
Citrobacter freundii  (17)
CL Item
Citrobacter species  (18)
CL Item
Enterobacter aerogenes  (19)
CL Item
Enterobacter agglomerans  (20)
CL Item
Enterobacter amnigenus  (21)
CL Item
Enterobacter cloacae  (22)
CL Item
Enterobacter gergoviae  (23)
CL Item
Enterobacter sakazakii  (24)
CL Item
Enterobacter species  (25)
CL Item
Enterobacteriaceae  (26)
CL Item
Enterococcus faecalis  (27)
CL Item
Enterococcus faecium  (28)
CL Item
Enterococcus species  (29)
CL Item
Escherichia coli  (30)
CL Item
Gram negative non-Enterobacteriaceae  (31)
CL Item
Haemophilus influenzae  (32)
CL Item
Haemophilus parainfluenzae  (33)
CL Item
Haemophilus species  (34)
CL Item
Klebsiella oxytoca  (35)
CL Item
Klebsiella pneumoniae  (36)
CL Item
Klebsiella species  (37)
CL Item
Moraxella species  (38)
CL Item
Morganella morganii  (39)
CL Item
Non-fermenting gram negative bacilli  (40)
CL Item
Oxidase positive gram negative rod  (41)
CL Item
Pantoea species  (42)
CL Item
Pasteurella haemolytica  (43)
CL Item
Pasteurella multocida  (44)
CL Item
Pasteurella species  (45)
CL Item
Proteus mirabilis  (46)
CL Item
Proteus penneri  (47)
CL Item
Proteus species  (48)
CL Item
Pseudomonas aeruginosa  (49)
CL Item
Pseudomonas alcaligenes  (50)
CL Item
Pseudomonas fluorescens  (51)
CL Item
Pseudomonas fluorescens/putida group  (52)
CL Item
Pseudomonas paucimobilis  (53)
CL Item
Pseudomonas species  (54)
CL Item
Pseudomonas stutzeri  (55)
CL Item
Pseudomonas vesicularis  (56)
CL Item
Ralstonia pickettii  (57)
CL Item
Serratia marcescens  (58)
CL Item
Serratia odorifera  (59)
CL Item
Serratia species  (60)
CL Item
Staphylococcus aureus  (61)
CL Item
Streptococcus agalactiae  (62)
CL Item
Streptococcus anginosis  (63)
CL Item
Streptococcus constellatus  (64)
CL Item
Streptococcus species - non-haemolytic  (65)
CL Item
Streptococcus dysgalactiae - equisimilis  (66)
CL Item
Streptococcus equisimilis  (67)
CL Item
Streptococcus intermedius  (68)
CL Item
Streptococcus pyogenes  (69)
CL Item
Streptococcus species  (70)
CL Item
Unidentified organism (71)
Other identification of microorganism
Item
If other identification of microorganism, please specify
text
C0205394 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
Item
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
text
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Code List
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
CL Item
Yes (Y)
CL Item
No (N)
Isolate(s) not sent to central laboratory, Reason
Item
If isolate(s) not sent to central laboratory, please specify reason
text
C1880016 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Item Group
Culture results for aseptic needle aspirate
C0430400 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0232920 (UMLS CUI-3)
C0936232 (UMLS CUI-4)
C0370199 (UMLS CUI-5)
Item
Was there any growth after 3 days?
text
C0430400 (UMLS CUI [1,1])
C0018284 (UMLS CUI [1,2])
Code List
Was there any growth after 3 days?
CL Item
No (no growth) (N)
CL Item
Yes (Y)
Item
If there was a growth, please specify
integer
C0018284 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If there was a growth, please specify
CL Item
Normal skin flora (1)
CL Item
Candida species, other yeast or mould (2)
CL Item
Pathogen isolated for culture (3)
Item
If normal flora was isolated, were any of the organisms isolated in pure culture?
text
C0205409 (UMLS CUI [1,1])
C0596932 (UMLS CUI [1,2])
Code List
If normal flora was isolated, were any of the organisms isolated in pure culture?
CL Item
No (N)
CL Item
Yes (Y)
Item
If organisms was isolated in pure culture, select organism
integer
C0029235 (UMLS CUI [1,1])
C0681875 (UMLS CUI [1,2])
Code List
If organisms was isolated in pure culture, select organism
CL Item
Coagulase negative staphylococci (1)
CL Item
Alpha-haemolytic Streptococcus species (not Group D) (2)
CL Item
Corynebacterium species (3)
CL Item
Micrococcus species (4)
Item Group
Isolate Detail for aseptic needle aspirate
C1764827 (UMLS CUI-1)
C0232920 (UMLS CUI-2)
C0370199 (UMLS CUI-3)
Isolate number
Item
Isolate number
text
C1764827 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Item
Semiquantitation/ growth estimate
integer
C0018284 (UMLS CUI [1])
Code List
Semiquantitation/ growth estimate
CL Item
1+ (1)
CL Item
2+ (2)
CL Item
3+ (3)
CL Item
4+ (4)
Item
Identification of microorganism
integer
C0205396 (UMLS CUI [1,1])
C0596932 (UMLS CUI [1,2])
Code List
Identification of microorganism
CL Item
Acinetobacter anitratus  (1)
CL Item
Acinetobacter calcoaceticus  (2)
CL Item
Acinetobacter lwoffi  (3)
CL Item
Acinetobacter species  (4)
CL Item
Aeromonas species  (5)
CL Item
Aeromonas hydrophila  (6)
CL Item
Bacillus species  (7)
CL Item
Beta haemolytic streptococcus - non-groupable  (8)
CL Item
Beta haemolytic streptococcus group A  (9)
CL Item
Beta haemolytic streptococcus group B  (10)
CL Item
Beta haemolytic streptococcus group C  (11)
CL Item
Beta haemolytic streptococcus group D  (12)
CL Item
Beta haemolytic streptococcus group D not Enterococcus  (13)
CL Item
Beta haemolytic streptococcus group F  (14)
CL Item
Beta haemolytic streptococcus group G  (15)
CL Item
Citrobacter diversus  (16)
CL Item
Citrobacter freundii  (17)
CL Item
Citrobacter species  (18)
CL Item
Enterobacter aerogenes  (19)
CL Item
Enterobacter agglomerans  (20)
CL Item
Enterobacter amnigenus  (21)
CL Item
Enterobacter cloacae  (22)
CL Item
Enterobacter gergoviae  (23)
CL Item
Enterobacter sakazakii  (24)
CL Item
Enterobacter species  (25)
CL Item
Enterobacteriaceae  (26)
CL Item
Enterococcus faecalis  (27)
CL Item
Enterococcus faecium  (28)
CL Item
Enterococcus species  (29)
CL Item
Escherichia coli  (30)
CL Item
Gram negative non-Enterobacteriaceae  (31)
CL Item
Haemophilus influenzae  (32)
CL Item
Haemophilus parainfluenzae  (33)
CL Item
Haemophilus species  (34)
CL Item
Klebsiella oxytoca  (35)
CL Item
Klebsiella pneumoniae  (36)
CL Item
Klebsiella species  (37)
CL Item
Moraxella species  (38)
CL Item
Morganella morganii  (39)
CL Item
Non-fermenting gram negative bacilli  (40)
CL Item
Oxidase positive gram negative rod  (41)
CL Item
Pantoea species  (42)
CL Item
Pasteurella haemolytica  (43)
CL Item
Pasteurella multocida  (44)
CL Item
Pasteurella species  (45)
CL Item
Proteus mirabilis  (46)
CL Item
Proteus penneri  (47)
CL Item
Proteus species  (48)
CL Item
Pseudomonas aeruginosa  (49)
CL Item
Pseudomonas alcaligenes  (50)
CL Item
Pseudomonas fluorescens  (51)
CL Item
Pseudomonas fluorescens/putida group  (52)
CL Item
Pseudomonas paucimobilis  (53)
CL Item
Pseudomonas species  (54)
CL Item
Pseudomonas stutzeri  (55)
CL Item
Pseudomonas vesicularis  (56)
CL Item
Ralstonia pickettii  (57)
CL Item
Serratia marcescens  (58)
CL Item
Serratia odorifera  (59)
CL Item
Serratia species  (60)
CL Item
Staphylococcus aureus  (61)
CL Item
Streptococcus agalactiae  (62)
CL Item
Streptococcus anginosis  (63)
CL Item
Streptococcus constellatus  (64)
CL Item
Streptococcus species - non-haemolytic  (65)
CL Item
Streptococcus dysgalactiae - equisimilis  (66)
CL Item
Streptococcus equisimilis  (67)
CL Item
Streptococcus intermedius  (68)
CL Item
Streptococcus pyogenes  (69)
CL Item
Streptococcus species  (70)
CL Item
Unidentified organism (71)
Other identification of microorganism
Item
If other identification of microorganism, please specify
text
C0205394 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
Item
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
text
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Code List
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
CL Item
Yes (Y)
CL Item
No (N)
Isolate(s) not sent to central laboratory, Reason
Item
If isolate(s) not sent to central laboratory, please specify reason
text
C1880016 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Item Group
Culture results for skin swab
C1123023 (UMLS CUI-1)
C1261188 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
Item
Was there any growth after 2 days?
text
C0430400 (UMLS CUI [1,1])
C0018284 (UMLS CUI [1,2])
Code List
Was there any growth after 2 days?
CL Item
No (no growth) (N)
CL Item
Yes (Y)
Item
If there was a growth, please specify
integer
C0018284 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Code List
If there was a growth, please specify
CL Item
Normal skin flora (1)
CL Item
Candida species, other yeast or mould (2)
CL Item
Pathogen isolated for culture (3)
Item Group
Isolate Detail for Skin Swab
C1764827 (UMLS CUI-1)
C1123023 (UMLS CUI-2)
C1261188 (UMLS CUI-3)
Isolate number
Item
Isolate number
text
C1764827 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Item
Semiquantitation/ growth estimate
integer
C0018284 (UMLS CUI [1])
Code List
Semiquantitation/ growth estimate
CL Item
1+ (1)
CL Item
2+ (2)
CL Item
3+ (3)
CL Item
4+ (4)
Item
Identification of microorganism
integer
C0205396 (UMLS CUI [1,1])
C0596932 (UMLS CUI [1,2])
Code List
Identification of microorganism
CL Item
Acinetobacter anitratus  (1)
CL Item
Acinetobacter calcoaceticus  (2)
CL Item
Acinetobacter lwoffi  (3)
CL Item
Acinetobacter species  (4)
CL Item
Aeromonas species  (5)
CL Item
Aeromonas hydrophila  (6)
CL Item
Bacillus species  (7)
CL Item
Beta haemolytic streptococcus - non-groupable  (8)
CL Item
Beta haemolytic streptococcus group A  (9)
CL Item
Beta haemolytic streptococcus group B  (10)
CL Item
Beta haemolytic streptococcus group C  (11)
CL Item
Beta haemolytic streptococcus group D  (12)
CL Item
Beta haemolytic streptococcus group D not Enterococcus  (13)
CL Item
Beta haemolytic streptococcus group F  (14)
CL Item
Beta haemolytic streptococcus group G  (15)
CL Item
Citrobacter diversus  (16)
CL Item
Citrobacter freundii  (17)
CL Item
Citrobacter species  (18)
CL Item
Enterobacter aerogenes  (19)
CL Item
Enterobacter agglomerans  (20)
CL Item
Enterobacter amnigenus  (21)
CL Item
Enterobacter cloacae  (22)
CL Item
Enterobacter gergoviae  (23)
CL Item
Enterobacter sakazakii  (24)
CL Item
Enterobacter species  (25)
CL Item
Enterobacteriaceae  (26)
CL Item
Enterococcus faecalis  (27)
CL Item
Enterococcus faecium  (28)
CL Item
Enterococcus species  (29)
CL Item
Escherichia coli  (30)
CL Item
Gram negative non-Enterobacteriaceae  (31)
CL Item
Haemophilus influenzae  (32)
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Haemophilus parainfluenzae  (33)
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Haemophilus species  (34)
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Klebsiella oxytoca  (35)
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Klebsiella pneumoniae  (36)
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Klebsiella species  (37)
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Moraxella species  (38)
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Morganella morganii  (39)
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Non-fermenting gram negative bacilli  (40)
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Oxidase positive gram negative rod  (41)
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Pantoea species  (42)
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Pasteurella haemolytica  (43)
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Pasteurella multocida  (44)
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Pasteurella species  (45)
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Proteus mirabilis  (46)
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Proteus penneri  (47)
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Proteus species  (48)
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Pseudomonas aeruginosa  (49)
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Pseudomonas alcaligenes  (50)
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Pseudomonas fluorescens  (51)
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Pseudomonas fluorescens/putida group  (52)
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Pseudomonas paucimobilis  (53)
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Pseudomonas species  (54)
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Pseudomonas stutzeri  (55)
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Pseudomonas vesicularis  (56)
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Ralstonia pickettii  (57)
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Serratia marcescens  (58)
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Serratia odorifera  (59)
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Serratia species  (60)
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Staphylococcus aureus  (61)
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Streptococcus agalactiae  (62)
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Streptococcus anginosis  (63)
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Streptococcus constellatus  (64)
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Streptococcus species - non-haemolytic  (65)
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Streptococcus dysgalactiae - equisimilis  (66)
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Streptococcus equisimilis  (67)
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Streptococcus intermedius  (68)
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Streptococcus pyogenes  (69)
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Streptococcus species  (70)
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Unidentified organism (71)
Other identification of microorganism
Item
If other identification of microorganism, please specify
text
C0205394 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
Item
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
text
C0370003 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
Code List
If a pathogen(s) was recovered, was the isolate(s) sent from the local laboratory to the central laboratory?
CL Item
Yes (Y)
CL Item
No (N)
Isolate(s) not sent to central laboratory, Reason
Item
If isolate(s) not sent to central laboratory, please specify reason
text
C1880016 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])

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