ID

16053

Descripción

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

Palabras clave

Versiones (1)
  1. 27/6/16 27/6/16 -
Subido en

27 de junio de 2016

DOI

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Licencia

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

Inglés

Lesion measurement & Skin Swab 2 Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 formularios  
Primary lesion measurement and dressing type (LESION)
Descripción

Primary lesion measurement and dressing type (LESION)

Lesion length
Descripción

Lesion length

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C1444754
UMLS CUI [1,2]
C0221198
mm
Lesion width
Descripción

Lesion width

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0487742
UMLS CUI [1,2]
C0221198
mm
Lesion area
Descripción

Lesion area

Tipo de datos

float

Unidades de medida
  • cm^2
Alias
UMLS CUI [1,1]
C0205146
UMLS CUI [1,2]
C0221198
cm^2
Lesion dressing type
Descripción

Lesion dressing type

Tipo de datos

text

Alias
UMLS CUI [1]
C3266208
Secondary lesion measurement and dressing type (LESION2)
Descripción

Secondary lesion measurement and dressing type (LESION2)

Lesion length
Descripción

Lesion length

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C1444754
UMLS CUI [1,2]
C0221198
mm
Lesion width
Descripción

Lesion width

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0487742
UMLS CUI [1,2]
C0221198
mm
Lesion area
Descripción

Lesion area

Tipo de datos

float

Unidades de medida
  • cm^2
Alias
UMLS CUI [1,1]
C0205146
UMLS CUI [1,2]
C0221198
cm^2
Lesion dressing type
Descripción

Lesion dressing type

Tipo de datos

text

Alias
UMLS CUI [1]
C3266208
Results for Skin Swab of secondary lesion (SKIN2)
Descripción

Results for Skin Swab of secondary lesion (SKIN2)

Was there any growth after 2 days?
Descripción

Was there any growth after 2 days?

Tipo de datos

text

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

If "yes", please specify:

Tipo de datos

text

Alias
UMLS CUI [1]
C2061903
Pathogen isolation for skin of secondary lesion (SKIN2_P)
Descripción

Pathogen isolation for skin of secondary lesion (SKIN2_P)

Isolate number
Descripción

Isolate number

Tipo de datos

integer

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

Quantitation

Tipo de datos

text

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

Identification

Tipo de datos

text

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

If "other", specify:

Tipo de datos

text

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

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

Tipo de datos

text

If "no", specify reason:
Descripción

If "no", specify reason:

Tipo de datos

text

Alias
UMLS CUI [1]
C0392360
Gram stain results for skin swab of secondary lesion (SKIN2_G1)
Descripción

Gram stain results for skin swab of secondary lesion (SKIN2_G1)

White Blood Cells (per 100x LPF)
Descripción

White Blood Cells (per 100x LPF)

Tipo de datos

text

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

Epithelial Cells (per 100x LPF)

Tipo de datos

text

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

Did the results indicate that organisms were present?

Tipo de datos

integer

Gram stain results for skin swab of secondary lesion (SKIN2_G2)
Descripción

Gram stain results for skin swab of secondary lesion (SKIN2_G2)

Gram positive bacilli
Descripción

Gram positive bacilli

Tipo de datos

text

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

Gram negative diplococci

Tipo de datos

text

Alias
UMLS CUI [1]
C0314755
Gram positive diplococci
Descripción

Gram positive diplococci

Tipo de datos

text

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

Gram positive cocci in clusters

Tipo de datos

text

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

Gram postive cocci in chains

Tipo de datos

text

Alias
UMLS CUI [1]
C0314749
Gram variable bacilli
Descripción

Gram variable bacilli

Tipo de datos

text

Alias
UMLS CUI [1]
C0744478
Gram negative bacilli
Descripción

Gram negative bacilli

Tipo de datos

text

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

Gram negative cocci

Tipo de datos

text

Alias
UMLS CUI [1]
C0314754
Gram negative coccobacilli
Descripción

Gram negative coccobacilli

Tipo de datos

text

Alias
UMLS CUI [1]
C1321360
Hyphal elements
Descripción

Hyphal elements

Tipo de datos

text

Alias
UMLS CUI [1]
C1319245
Yeast
Descripción

Yeast

Tipo de datos

text

Alias
UMLS CUI [1]
C0043393
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Similar models

Lesion measurement & Skin Swab 2 Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Primary lesion measurement and dressing type (LESION)
Lesion length
Item
Lesion length
integer
C1444754 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Lesion width
Item
Lesion width
integer
C0487742 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Lesion area
Item
Lesion area
float
C0205146 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Lesion dressing type
text
C3266208 (UMLS CUI [1])
Lesion dressing type
Code List
Lesion dressing type
CL Item
None (N)
CL Item
Semi-occlusive (S)
CL Item
Occlusive (O)
Item Group
Secondary lesion measurement and dressing type (LESION2)
Lesion length
Item
Lesion length
integer
C1444754 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Lesion width
Item
Lesion width
integer
C0487742 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Lesion area
Item
Lesion area
float
C0205146 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Lesion dressing type
text
C3266208 (UMLS CUI [1])
Lesion dressing type
Code List
Lesion dressing type
CL Item
None (N)
CL Item
Semi-occlusive (S)
CL Item
Occlusive (O)
Item Group
Results for Skin Swab of secondary lesion (SKIN2)
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 of secondary lesion (SKIN2_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 secondary lesion (SKIN2_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 secondary lesion (SKIN2_G2)
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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