ID

35409

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 evaluation, Clinical outcome and Description of Clinical Failure form. It has to be filled in for Visit 2-5. Note for Clinical outcome determination: At the On-Therapy visit, the bacteriology sample and clinical outcome determination was only to be conducted in cases of clinical failure and/or withdrawal.

Link

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

Trefwoorden

Versies (2)
  1. 04-03-19 04-03-19 -
  2. 11-03-19 11-03-19 -
Houder van rechten

GlaxoSmithKline

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4 maart 2019

DOI

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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

Engels

Clinical evaluation, Clinical outcome, Description of Clinical Failure

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Type
Beschrijving

Visit Type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Clinical evaluation
Beschrijving

Clinical evaluation

Alias
UMLS CUI-1
C1261322
Clinical evaluation
Beschrijving

Clinical evaluation

Datatype

integer

Alias
UMLS CUI [1]
C1261322
Subject withdrawn from treatment?
Beschrijving

Withdrawal of subject

Datatype

text

Alias
UMLS CUI [1]
C0422727
Clinical Outcome Determination
Beschrijving

Clinical Outcome Determination

Alias
UMLS CUI-1
C1547647
Clinical outcome
Beschrijving

Clinical outcome

Datatype

integer

Alias
UMLS CUI [1]
C1547647
If clinical failure, please note the date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3640841
If clinical outcome is unable to determine, please specify
Beschrijving

Clinical outcome, specification

Datatype

text

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C2348235
Description of Clinical Failure
Beschrijving

Description of Clinical Failure

Alias
UMLS CUI-1
C0678257
UMLS CUI-2
C3640841
Pus/exudate
Beschrijving

The subject's skin infection worsened due to an increase in. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C0015388
UMLS CUI [2]
C0034161
Erythema/inflammation
Beschrijving

The subject's skin infection worsened due to an increase in. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C0041834
UMLS CUI [2]
C0021368
Tissue swelling
Beschrijving

The subject's skin infection worsened due to an increase in. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0040300
Pain
Beschrijving

The subject's skin infection worsened due to an increase in. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C0030193
Not applicable
Beschrijving

The subject's skin infection worsened due to an increase in. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C1272460
The subject's skin infection advanced to one of these conditions
Beschrijving

Skin infection, condition

Datatype

integer

Alias
UMLS CUI [1,1]
C0037278
UMLS CUI [1,2]
C1719933
Fever
Beschrijving

The subject developed signs/symptoms of systemic infection. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C0015967
Chills
Beschrijving

The subject developed signs/symptoms of systemic infection. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C0085593
Increased respiration rate
Beschrijving

The subject developed signs/symptoms of systemic infection. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205217
UMLS CUI [1,2]
C0231832
Increased heart rate
Beschrijving

The subject developed signs/symptoms of systemic infection. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205217
UMLS CUI [1,2]
C0018810
Not applicable
Beschrijving

The subject developed signs/symptoms of systemic infection. (check all that apply)

Datatype

boolean

Alias
UMLS CUI [1]
C1272460
Other description of clinical failure
Beschrijving

Other description of clinical failure

Datatype

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C3640841
If other description of clinical failure, please specify
Beschrijving

Other description of clinical failure, specification

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C3640841
UMLS CUI [1,4]
C2348235
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Similar models

Clinical evaluation, Clinical outcome, Description of Clinical Failure

1 Formulieren
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])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 2 (1)
CL Item
Visit 3 (2)
CL Item
Visit 4 (3)
CL Item
Visit 5 (4)
Item Group
Clinical evaluation
C1261322 (UMLS CUI-1)
Item
Clinical evaluation
integer
C1261322 (UMLS CUI [1])
Clinical evaluation
Code List
Clinical evaluation
CL Item
Resolved (1)
CL Item
Improvement (2)
CL Item
No change (3)
CL Item
Worsening (4)
CL Item
Unable to determine (5)
Item
Subject withdrawn from treatment?
text
C0422727 (UMLS CUI [1])
Withdrawal of subject
Code List
Subject withdrawn from treatment?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Clinical Outcome Determination
C1547647 (UMLS CUI-1)
Item
Clinical outcome
integer
C1547647 (UMLS CUI [1])
Clinical outcome
Code List
Clinical outcome
CL Item
Clinical success (1)
CL Item
Clinical improvement (2)
CL Item
Clinical failure (3)
CL Item
Unable to determine (4)
Date of clinical failure
Item
If clinical failure, please note the date
date
C0011008 (UMLS CUI [1,1])
C3640841 (UMLS CUI [1,2])
Clinical outcome, specification
Item
If clinical outcome is unable to determine, please specify
text
C1547647 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Description of Clinical Failure
C0678257 (UMLS CUI-1)
C3640841 (UMLS CUI-2)
Pus/exudate
Item
Pus/exudate
boolean
C0015388 (UMLS CUI [1])
C0034161 (UMLS CUI [2])
Erythema/inflammation
Item
Erythema/inflammation
boolean
C0041834 (UMLS CUI [1])
C0021368 (UMLS CUI [2])
Tissue swelling
Item
Tissue swelling
boolean
C0038999 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Not applicable
Item
Not applicable
boolean
C1272460 (UMLS CUI [1])
Item
The subject's skin infection advanced to one of these conditions
integer
C0037278 (UMLS CUI [1,1])
C1719933 (UMLS CUI [1,2])
Skin infection, condition
Code List
The subject's skin infection advanced to one of these conditions
CL Item
Abscess (1)
CL Item
Cellulitis (2)
CL Item
Not applicable (3)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Chills
Item
Chills
boolean
C0085593 (UMLS CUI [1])
Increased respiration rate
Item
Increased respiration rate
boolean
C0205217 (UMLS CUI [1,1])
C0231832 (UMLS CUI [1,2])
Increased heart rate
Item
Increased heart rate
boolean
C0205217 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Not applicable
Item
Not applicable
boolean
C1272460 (UMLS CUI [1])
Item
Other description of clinical failure
integer
C0205394 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C3640841 (UMLS CUI [1,3])
Other description of clinical failure
Code List
Other description of clinical failure
CL Item
Not applicable (1)
CL Item
Other (2)
Other description of clinical failure, specification
Item
If other description of clinical failure, please specify
text
C0205394 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C3640841 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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