ID

16050

Description

Documentation part: Skin Swab 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

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
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June 27, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Skin Swab Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

English

Skin Swab Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 forms  
Culture Results for Skin Swab of Primary Lesion
Description

Culture Results for Skin Swab of Primary Lesion

Was there any growth after 2 days?
Description

Was there any growth after 2 days?

Data type

text

Alias
UMLS CUI [1,1]
C2266652
UMLS CUI [1,2]
C2061903
If "yes", please specify:
Description

If "yes", please specify:

Data type

text

Alias
UMLS CUI [1]
C2061903
Pathogen Isolation for Skin Swab of Primary Lesion (SKIN_P)
Description

Pathogen Isolation for Skin Swab of Primary Lesion (SKIN_P)

Isolate number
Description

Isolate number

Data type

integer

Alias
UMLS CUI [1,1]
C1764827
UMLS CUI [1,2]
C0449788
Quantitation: Colony count/growth estimate
Description

Quantitation

Data type

text

Alias
UMLS CUI [1]
C0368993
UMLS CUI [2]
C0427944
Identification
Description

Identification

Data type

text

Alias
UMLS CUI [1]
C1982072
If "other", specify:
Description

If "other", specify:

Data type

text

Alias
UMLS CUI [1]
C0205394
If pathogen(s) was recovered, were isolates sent from the local laboratory to the Central Laboratory (QUEST)?
Description

If pathogen(s) was recovered, were isolates sent from the local laboratory to the Central Laboratory (QUEST)?

Data type

text

If "no", specify reason:
Description

If "no", specify reason:

Data type

text

Alias
UMLS CUI [1]
C0392360
Gram Stain Results for Skin Swab of Primary Lesion (SKIN_G1)
Description

Gram Stain Results for Skin Swab of Primary Lesion (SKIN_G1)

White Blood Cells (per 100x LPF)
Description

White Blood Cells (per 100x LPF)

Data type

text

Alias
UMLS CUI [1]
C0023516
Epithelial Cells (per 100x LPF)
Description

Epithelial Cells (per 100x LPF)

Data type

text

Alias
UMLS CUI [1]
C1273342
Did the result indicate that organisms were present?
Description

Did the results indicate that organisms were present?

Data type

integer

Gram stain results for skin swab of primary lesion
Description

Gram stain results for skin swab of primary lesion

Gram positive bacilli
Description

Gram positive bacilli

Data type

text

Alias
UMLS CUI [1,1]
C0018154
UMLS CUI [1,2]
C1040746
Gram negative diplococci
Description

Gram negative diplococci

Data type

text

Alias
UMLS CUI [1]
C0314755
Gram positive diplococci
Description

Gram positive diplococci

Data type

text

Alias
UMLS CUI [1]
C0314751
Gram positive cocci in clusters
Description

Gram positive cocci in clusters

Data type

text

Alias
UMLS CUI [1]
C0314750
Gram postive cocci in chains
Description

Gram postive cocci in chains

Data type

text

Alias
UMLS CUI [1]
C0314749
Gram variable bacilli
Description

Gram variable bacilli

Data type

text

Alias
UMLS CUI [1]
C0744478
Gram negative bacilli
Description

Gram negative bacilli

Data type

text

Alias
UMLS CUI [1,1]
C0018150
UMLS CUI [1,2]
C1040746
Gram negative cocci
Description

Gram negative cocci

Data type

text

Alias
UMLS CUI [1]
C0314754
Gram negative coccobacilli
Description

Gram negative coccobacilli

Data type

text

Alias
UMLS CUI [1]
C1321360
Hyphal elements
Description

Hyphal elements

Data type

text

Alias
UMLS CUI [1]
C1319245
Yeast
Description

Yeast

Data type

text

Alias
UMLS CUI [1]
C0043393
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Similar models

Skin Swab Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Culture Results for Skin Swab of Primary Lesion
Item
Was there any growth after 2 days?
text
C2266652 (UMLS CUI [1,1])
C2061903 (UMLS CUI [1,2])
Was there any growth after 2 days?
Code List
Was there any growth after 2 days?
CL Item
No (no growth) (N)
CL Item
Yes (Y)
Item
If "yes", please specify:
text
C2061903 (UMLS CUI [1])
If
Code List
If "yes", please specify:
CL Item
Normal flora (1)
CL Item
Candida species, yeast or mould (2)
CL Item
Pathogen isolated for culture (3)
Item Group
Pathogen Isolation for Skin Swab of Primary Lesion (SKIN_P)
Isolate number
Item
Isolate number
integer
C1764827 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Quantitation: Colony count/growth estimate
text
C0368993 (UMLS CUI [1])
C0427944 (UMLS CUI [2])
Quantitation
Code List
Quantitation: Colony count/growth estimate
CL Item
1+ (10)
CL Item
2+ (11)
CL Item
3+ (12)
CL Item
4+ (13)
Item
Identification
text
C1982072 (UMLS CUI [1])
Identification
Code List
Identification
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
If pathogen(s) was recovered, were isolates sent from the local laboratory to the Central Laboratory (QUEST)?
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])
Item Group
Gram Stain Results for Skin Swab of Primary Lesion (SKIN_G1)
Item
White Blood Cells (per 100x LPF)
text
C0023516 (UMLS CUI [1])
White Blood Cells (per 100x LPF)
Code List
White Blood Cells (per 100x LPF)
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
Epithelial Cells (per 100x LPF)
text
C1273342 (UMLS CUI [1])
Epithelial Cells (per 100x LPF)
Code List
Epithelial Cells (per 100x LPF)
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
Did the results indicate that organisms were present?
Code List
Did the result indicate that organisms were present?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Gram stain results for skin swab of primary lesion
Item
Gram positive bacilli
text
C0018154 (UMLS CUI [1,1])
C1040746 (UMLS CUI [1,2])
Gram positive bacilli
Code List
Gram positive bacilli
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 diplococci
text
C0314755 (UMLS CUI [1])
Gram negative diplococci
Code List
Gram negative diplococci
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 positive diplococci
text
C0314751 (UMLS CUI [1])
Gram positive diplococci
Code List
Gram positive diplococci
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 positive cocci in clusters
text
C0314750 (UMLS CUI [1])
Gram positive cocci in clusters
Code List
Gram positive cocci in clusters
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 postive cocci in chains
text
C0314749 (UMLS CUI [1])
Gram postive cocci in chains
Code List
Gram postive cocci in chains
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 variable bacilli
text
C0744478 (UMLS CUI [1])
Gram variable bacilli
Code List
Gram variable bacilli
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])
Gram negative bacilli
Code List
Gram negative bacilli
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 cocci
text
C0314754 (UMLS CUI [1])
Gram negative cocci
Code List
Gram negative cocci
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 coccobacilli
text
C1321360 (UMLS CUI [1])
Gram negative coccobacilli
Code List
Gram negative coccobacilli
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
Hyphal elements
text
C1319245 (UMLS CUI [1])
Hyphal elements
Code List
Hyphal elements
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
Yeast
text
C0043393 (UMLS CUI [1])
Yeast
Code List
Yeast
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)
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