ID

35674

Beschrijving

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 Clinical diagnosis form. It has to be filled in for screening (Visit 1, Baseline).

Link

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

Trefwoorden

  1. 11-03-19 11-03-19 -
  2. 15-03-19 15-03-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 maart 2019

DOI

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Licentie

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

Clinical diagnosis

  1. StudyEvent: ODM
    1. Clinical diagnosis
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Clinical diagnosis
Beschrijving

Clinical diagnosis

Alias
UMLS CUI-1
C0332140
Diagnosis of bacterial skin infection
Beschrijving

Diagnosis of bacterial skin infection

Datatype

integer

Alias
UMLS CUI [1,1]
C0037278
UMLS CUI [1,2]
C0004623
[Other] Medical Conditions
Beschrijving

[Other] Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Specific condition
Beschrijving

Other medical condition

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Medical history or condition status
Beschrijving

Medical history

Datatype

integer

Alias
UMLS CUI [1]
C0262926

Similar models

Clinical diagnosis

  1. StudyEvent: ODM
    1. Clinical diagnosis
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Clinical diagnosis
C0332140 (UMLS CUI-1)
Item
Diagnosis of bacterial skin infection
integer
C0037278 (UMLS CUI [1,1])
C0004623 (UMLS CUI [1,2])
Code List
Diagnosis of bacterial skin infection
CL Item
Secondarily infected abrasion (1)
CL Item
Secondarily infected laceration (2)
CL Item
Secondarily infected sutured wound (3)
CL Item
Impetiginous lesion bullous (4)
CL Item
Impetiginous lesion non-bullous (5)
Item Group
[Other] Medical Conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Specific condition
Item
Specific condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Medical history or condition status
integer
C0262926 (UMLS CUI [1])
Code List
Medical history or condition status
CL Item
Current (1)
CL Item
Past (2)

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