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
Versioner (3)
- 04/03/19 04/03/19 -
- 11/03/19 11/03/19 -
- 12/03/19 12/03/19 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 marzo 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
- StudyEvent: ODM
Beskrivning
Nasal Swab Sample
Alias
- UMLS CUI-1
- C3669207
Beskrivning
Nasal Swab Sample
Datatyp
text
Alias
- UMLS CUI [1]
- C3669207
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C3669207
Beskrivning
Reason, no sample taken
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C3669207
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
Beskrivning
Culture Results for Nasal Swab
Alias
- UMLS CUI-1
- C3669207
- UMLS CUI-2
- C1274040
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1]
- C0429928
Beskrivning
Growth of culture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018284
- UMLS CUI [1,2]
- C3669207
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
Beskrivning
Isolate Detail for Nasal Swab
Alias
- UMLS CUI-1
- C1764827
- UMLS CUI-2
- C3669207
Beskrivning
Isolate number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0237753
Beskrivning
Visit Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
Beskrivning
Semiquantitation/ growth estimate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018284
Beskrivning
Identification of microorganism
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205396
- UMLS CUI [1,2]
- C0596932
Beskrivning
Other identification of microorganism
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205396
- UMLS CUI [1,3]
- C0596932
Beskrivning
Recovering of Staphylococcus aureus
Datatyp
integer
Alias
- UMLS CUI [1]
- C0038172
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
Beskrivning
Wound/Lesion specimen - bacteriology
Alias
- UMLS CUI-1
- C0043241
- UMLS CUI-2
- C0004644
Beskrivning
Sample taken
Datatyp
text
Alias
- UMLS CUI [1]
- C0200345
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C3669207
Beskrivning
Reason, no sample taken
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C3669207
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
Beskrivning
Specimen collection method
Datatyp
integer
Alias
- UMLS CUI [1]
- C1547864
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
Beskrivning
Gram Stain Results for Wound/Lesion Bacteriology Specimen
Alias
- UMLS CUI-1
- C0061856
- UMLS CUI-2
- C1274040
- UMLS CUI-3
- C0004644
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2826247
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0429928
Beskrivning
White Blood Cells
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
Epithelial Cells
Datatyp
integer
Alias
- UMLS CUI [1]
- C1273342
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
Beskrivning
Results of Bacteria
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0004611
- UMLS CUI [1,2]
- C1254595
Beskrivning
Culture results for skin curettage
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C0010468
- UMLS CUI-3
- C1254595
Beskrivning
Growth of culture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C0018284
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
Beskrivning
Isolate Detail for Skin Curettage
Alias
- UMLS CUI-1
- C1764827
- UMLS CUI-2
- C1123023
- UMLS CUI-3
- C0010468
Beskrivning
Isolate number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0237753
Beskrivning
Visit Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
Beskrivning
Semiquantitation/ growth estimate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018284
Beskrivning
Identification of microorganism
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205396
- UMLS CUI [1,2]
- C0596932
Beskrivning
Other identification of microorganism
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205396
- UMLS CUI [1,3]
- C0596932
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
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
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
Beskrivning
Growth of culture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C0018284
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
Beskrivning
Isolation of organism in pure culture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205409
- UMLS CUI [1,2]
- C0596932
Beskrivning
Organism selection
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0029235
- UMLS CUI [1,2]
- C0681875
Beskrivning
Isolate Detail for aseptic needle aspirate
Alias
- UMLS CUI-1
- C1764827
- UMLS CUI-2
- C0232920
- UMLS CUI-3
- C0370199
Beskrivning
Isolate number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0237753
Beskrivning
Visit Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
Beskrivning
Semiquantitation/ growth estimate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018284
Beskrivning
Identification of microorganism
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205396
- UMLS CUI [1,2]
- C0596932
Beskrivning
Other identification of microorganism
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205396
- UMLS CUI [1,3]
- C0596932
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
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
Beskrivning
Culture results for skin swab
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C1261188
- UMLS CUI-3
- C1254595
Beskrivning
Growth of culture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430400
- UMLS CUI [1,2]
- C0018284
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
Beskrivning
Isolate Detail for Skin Swab
Alias
- UMLS CUI-1
- C1764827
- UMLS CUI-2
- C1123023
- UMLS CUI-3
- C1261188
Beskrivning
Isolate number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1764827
- UMLS CUI [1,2]
- C0237753
Beskrivning
Visit Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
Beskrivning
Semiquantitation/ growth estimate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018284
Beskrivning
Identification of microorganism
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0205396
- UMLS CUI [1,2]
- C0596932
Beskrivning
Other identification of microorganism
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205396
- UMLS CUI [1,3]
- C0596932
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
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
- StudyEvent: ODM
C3669207 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
C3669207 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C3669207 (UMLS CUI [1,4])
C1274040 (UMLS CUI-2)
C3669207 (UMLS CUI [1,2])
C0018284 (UMLS CUI [1,2])
C3669207 (UMLS CUI [1,3])
C3669207 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
C1880016 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0004644 (UMLS CUI-2)
C3669207 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
C3669207 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C3669207 (UMLS CUI [1,4])
C1123023 (UMLS CUI [1,2])
C1261188 (UMLS CUI [1,3])
C1547864 (UMLS CUI [1,4])
C1274040 (UMLS CUI-2)
C0004644 (UMLS CUI-3)
C2826247 (UMLS CUI [1,2])
C0429928 (UMLS CUI [1,2])
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])
C1254595 (UMLS CUI [1,2])
C0010468 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0018284 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1123023 (UMLS CUI-2)
C0010468 (UMLS CUI-3)
C0237753 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1274040 (UMLS CUI-2)
C0232920 (UMLS CUI-3)
C0936232 (UMLS CUI-4)
C0370199 (UMLS CUI-5)
C0018284 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,2])
C0681875 (UMLS CUI [1,2])
C0232920 (UMLS CUI-2)
C0370199 (UMLS CUI-3)
C0237753 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1261188 (UMLS CUI-2)
C1254595 (UMLS CUI-3)
C0018284 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1123023 (UMLS CUI-2)
C1261188 (UMLS CUI-3)
C0237753 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,2])
C0205396 (UMLS CUI [1,2])
C0596932 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1880016 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])