ID

35590

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

Länk

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

Nyckelord

  1. 2019-03-11 2019-03-11 -
  2. 2019-03-15 2019-03-15 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 mars 2019

DOI

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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

Clinical diagnosis

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

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Clinical diagnosis
Beskrivning

Clinical diagnosis

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

Diagnosis of bacterial skin infection

Datatyp

integer

Alias
UMLS CUI [1,1]
C0037278
UMLS CUI [1,2]
C0004623
Specific condition
Beskrivning

Other medical condition

Datatyp

text

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

Medical history

Datatyp

integer

Alias
UMLS CUI [1]
C0262926

Similar models

Clinical diagnosis

  1. StudyEvent: ODM
    1. Clinical diagnosis
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])
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)
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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