Informações:
Falhas:
ID
16053
Descrição
Documentation part: Lesion measurement & Skin Swab 2 A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo. ClinicalTrials.gov Identifier: NCT00133874 Other Study ID Numbers: TOC100224 Responsible Party: GlaxoSmithKline
Palavras-chave
Versões (1)
- 27/06/2016 27/06/2016 -
Transferido a
27 de junho de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Lesion measurement & Skin Swab 2 Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874
Lesion measurement & Skin Swab 2 Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874
Similar models
Lesion measurement & Skin Swab 2 Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Lesion length
Item
Lesion length
integer
C1444754 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
Lesion width
Item
Lesion width
integer
C0487742 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
Lesion area
Item
Lesion area
float
C0205146 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (N)
CL Item
Semi-occlusive (S)
CL Item
Occlusive (O)
Lesion length
Item
Lesion length
integer
C1444754 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
Lesion width
Item
Lesion width
integer
C0487742 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
Lesion area
Item
Lesion area
float
C0205146 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (N)
CL Item
Semi-occlusive (S)
CL Item
Occlusive (O)
Item
Was there any growth after 2 days?
text
C2266652 (UMLS CUI [1,1])
C2061903 (UMLS CUI [1,2])
C2061903 (UMLS CUI [1,2])
CL Item
No (no growth) (N)
CL Item
Yes (Y)
CL Item
Normal flora (1)
CL Item
Candida species, yeast or mould (2)
CL Item
Pathogen isolated for culture (3)
Isolate number
Item
Isolate number
integer
C1764827 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Item
Quantitation: Colony count/growth estimate
text
C0368993 (UMLS CUI [1])
C0427944 (UMLS CUI [2])
C0427944 (UMLS CUI [2])
CL Item
1+ (10)
CL Item
2+ (11)
CL Item
3+ (12)
CL Item
4+ (13)
CL Item
Acinetobacter anitratus (0100-20)
CL Item
Acinetobacter calcoaceticus (0100-30)
CL Item
Acinetobacter lwoffi (0100-40)
CL Item
Acinetobacter species (0100-10)
CL Item
Bacillus species (0310-10)
CL Item
Beta haemolytic streptococcus (2300-25)
CL Item
Beta haemolytic streptococcus - non-groupable (2300-26)
CL Item
Beta haemolytic streptococcus group A (2300-45)
CL Item
Beta haemolytic streptococcus group B (2300-50)
CL Item
Beta haemolytic streptococcus group C (2300-55)
CL Item
Beta haemolytic streptococcus group D (2300-56)
CL Item
Beta haemolytic streptococcus group D not Enterococcus (2300-57)
CL Item
Beta haemolytic streptococcus group F (2300-62)
CL Item
Beta haemolytic streptococcus group G (2300-58)
CL Item
Citrobacter diversus (0500-20)
CL Item
Citrobacter freundii (0500-30)
CL Item
Citrobacter species (0500-10)
CL Item
Corynebacterium species (0520-10)
CL Item
Enterobacter aerogenes (0700-20)
CL Item
Enterobacter agglomerans (0700-30)
CL Item
Enterobacter amnigenus (0700-35)
CL Item
Enterobacter cloacae (0700-40)
CL Item
Enterobacter gergoviae (0700-45)
CL Item
Enterobacter skazakii (0700-60)
CL Item
Enterobacter species (0700-10)
CL Item
Enterobacteriaceae (0995-50)
CL Item
Enterococcus faecalis (0800-40)
CL Item
Enterococcus faecium (0800-35)
CL Item
Enterococcus species (0800-10)
CL Item
Escherichia coli (0900-20)
CL Item
Gamma haemolytic streptococcus (2300-44)
CL Item
Gram negative non-Enterobacteriaceae (0995-60)
CL Item
Haemophilus influenzae (1000-30)
CL Item
Haemophilus parainfluenzae (1000-40)
CL Item
Haemophilus species (1000-10)
CL Item
Klebsiella oxytoca (1100-20)
CL Item
Klepsiella pneumoniae (1100-40)
CL Item
Klebsiella pneumoniae I (1100-41)
CL Item
Klebsiella species (1100-10)
CL Item
Mixed microbial flora (0012-00)
CL Item
Moraxella catarrhalis (0400-20)
CL Item
Moraxella species (1250-10)
CL Item
Morganella morganii (1300-20)
CL Item
Neisseria meningitidis (1400-30)
CL Item
Neisseria species (1400-10)
CL Item
Non-fermenting gram negative bacilli (1430-10)
CL Item
Oxidase positive gram negative rod (1442-10)
CL Item
Pantoea species (1443-10)
CL Item
Pasteurella haemolytica (1450-15)
CL Item
Pasteurella multocida (1450-20)
CL Item
Pasteurella species (1450-10)
CL Item
Proteus mirabilis (1500-20)
CL Item
Proteus penneri (1500-40)
CL Item
Proteus species (1500-10)
CL Item
Pseudomonas aeruginosa (1700-20)
CL Item
Pseudomonas alcaligenes (1700-22)
CL Item
Pseudomonas fluorescens (1700-25)
CL Item
Pseudomonas fluorescente/putida group (1700-27)
CL Item
Pseudomonas paucimobilis (1700-35)
CL Item
Pseudomonas species (1700-10)
CL Item
Pseudomonas stutzeri (1700-50)
CL Item
Pseudomonas vesicularis (1700-60)
CL Item
Ralstonia pickettii (1725-10)
CL Item
Serratia marcescens (2000-20)
CL Item
Serratia odorifera (2000-35)
CL Item
Serratia species (2000-10)
CL Item
Staphylococcus aureus (2200-20)
CL Item
Streptococcus agalactiae (2300-20)
CL Item
Streptococcus anginosis (2300-24)
CL Item
Streptococcus constellatus (2300-32)
CL Item
Streptococcus dysgalactiae (2300-35)
CL Item
Streptococcus dysgalactiae - equisimilis (2300-37)
CL Item
Streptococcus equi (2300-36)
CL Item
Streptococcus equisimilis (2300-38)
CL Item
Streptococcus intermedius (2300-59)
CL Item
Streptococcus pneumoniae (2300-70)
CL Item
Streptococcus pyogenes (2300-80)
CL Item
Streptococcus species (2300-10)
CL Item
Streptococcus species - non-haemolytic (2300-05)
CL Item
Streptococcus viridans (2300-90)
CL Item
Unidentified organsim (0000-00)
If "other", specify:
Item
If "other", specify:
text
C0205394 (UMLS CUI [1])
Item
If pathogen(s) was recovered, were isolates sent from the local laboratory to the Central Laboratory (QUEST)?
text
Code List
If pathogen(s) was recovered, were isolates sent from the local laboratory to the Central Laboratory (QUEST)?
CL Item
Yes (Y)
CL Item
No (N)
If "no", specify reason:
Item
If "no", specify reason:
text
C0392360 (UMLS CUI [1])
CL Item
0 or none (0)
CL Item
1-9 or few (1)
CL Item
10-24 or moderate (2)
CL Item
>=25 or many (3)
CL Item
0 or none (0)
CL Item
1-9 or few (1)
CL Item
10-24 or moderate (2)
CL Item
>=25 or many (3)
Item
Did the result indicate that organisms were present?
integer
Code List
Did the result indicate that organisms were present?
CL Item
Yes (Y)
CL Item
No (N)
Item
Gram positive bacilli
text
C0018154 (UMLS CUI [1,1])
C1040746 (UMLS CUI [1,2])
C1040746 (UMLS CUI [1,2])
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
Item
Gram negative bacilli
text
C0018150 (UMLS CUI [1,1])
C1040746 (UMLS CUI [1,2])
C1040746 (UMLS CUI [1,2])
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)
CL Item
0 or none (0)
CL Item
1-4 (9)
CL Item
5-9 (10)
CL Item
10-50 or moderate (6)
CL Item
>50 or many (7)