ID

35627

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 Wound or lesion details and SIRS score form. It has to be filled in for each Visit (1-5).

Link

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

Trefwoorden

  1. 11-03-19 11-03-19 -
  2. 12-03-19 12-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 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

Wound or lesion details, SIRS score

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
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Wound or lesion details
Beschrijving

Wound or lesion details

Alias
UMLS CUI-1
C0043250
UMLS CUI-2
C0221198
Left or right side?
Beschrijving

Side of wound/lesion

Datatype

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0043250
Front or back of the body?
Beschrijving

Site of wound/lesion

Datatype

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0043250
Wound in the front
Beschrijving

Wound in the front

Datatype

integer

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205094
Wound in the back
Beschrijving

Wound in the back

Datatype

integer

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205095
Wound length
Beschrijving

Wound length

Datatype

float

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C1444754
Wound width
Beschrijving

Wound width

Datatype

float

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0487742
Wound area
Beschrijving

Wound area

Datatype

text

Alias
UMLS CUI [1]
C3534343
SIRS score
Beschrijving

SIRS score

Alias
UMLS CUI-1
C0243026
UMLS CUI-2
C2964552
SIRS total score
Beschrijving

SIRS total score

Datatype

text

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C2964552

Similar models

Wound or lesion details, SIRS score

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])
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)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Wound or lesion details
C0043250 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
Item
Left or right side?
integer
C0441987 (UMLS CUI [1,1])
C0043250 (UMLS CUI [1,2])
Code List
Left or right side?
CL Item
Right (1)
CL Item
Left (2)
CL Item
Midline (3)
Item
Front or back of the body?
integer
C1515974 (UMLS CUI [1,1])
C0043250 (UMLS CUI [1,2])
Code List
Front or back of the body?
CL Item
Front (1)
CL Item
Back (2)
Item
Wound in the front
integer
C0043250 (UMLS CUI [1,1])
C0205094 (UMLS CUI [1,2])
Code List
Wound in the front
CL Item
Face neck  (1)
CL Item
Anterior trunk  (2)
CL Item
Genitalia  (3)
CL Item
Arms  (4)
CL Item
Forearms  (5)
CL Item
Palms  (6)
CL Item
Thighs  (7)
CL Item
Knees (8)
CL Item
Legs  (9)
CL Item
Feet (dorsal)  (10)
CL Item
Fingers (11)
Item
Wound in the back
integer
C0043250 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
Code List
Wound in the back
CL Item
Scalp neck  (1)
CL Item
Back  (2)
CL Item
Buttocks  (3)
CL Item
Arms  (4)
CL Item
Elbow  (5)
CL Item
Forearms  (6)
CL Item
Hand (dorsal)  (7)
CL Item
Thighs  (8)
CL Item
Legs (9)
CL Item
Soles  (10)
CL Item
Fingers (11)
CL Item
Toes (12)
Wound length
Item
Wound length
float
C0043250 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Wound width
Item
Wound width
float
C0043250 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
Wound area
Item
Wound area
text
C3534343 (UMLS CUI [1])
Item Group
SIRS score
C0243026 (UMLS CUI-1)
C2964552 (UMLS CUI-2)
SIRS total score
Item
SIRS total score
text
C0243026 (UMLS CUI [1,1])
C2964552 (UMLS CUI [1,2])

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