ID

16030

Beschreibung

Documentation part: SIRS & Nasal 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

Stichworte

Versionen (1)
  1. 26.06.16 26.06.16 -
Hochgeladen am

26. Juni 2016

DOI

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Creative Commons BY-NC 3.0
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SIRS & Nasal swab Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

Englisch

SIRS & Nasal swab Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 Formulare  
Skin Infection Rating Scale
Beschreibung

Skin Infection Rating Scale

Instructions for rating
Beschreibung

Rating should be based on a clinical interview and clinical examination. The rater must decide whether the rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). DEFINITIONS 0 Absent =No evidence of the signs or symptoms 2 Mild =Signs/symptoms are present but not intense 4 Moderate Signs/symptoms are clearly evident and are somewhat bothersome to the subject 6 Severe signs/symptoms are clearly evident, intense, extremely bothersome to the subject

Datentyp

text

Exsudate/Pus
Beschreibung

Exsudate/Pus

Datentyp

text

Alias
UMLS CUI [1]
C0015388
UMLS CUI [2]
C0034161
Crusting
Beschreibung

Crusting

Datentyp

text

Alias
UMLS CUI [1]
C0205204
Erythema/Inflammation
Beschreibung

Erythema/Inflammation

Datentyp

text

Alias
UMLS CUI [1]
C0041834
UMLS CUI [2]
C0021368
Tissue warmth
Beschreibung

Tissue warmth

Datentyp

text

Alias
UMLS CUI [1]
C2184256
Tissue oedema
Beschreibung

Tissue oedema

Datentyp

text

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C0040300
Itching
Beschreibung

Itching

Datentyp

text

Alias
UMLS CUI [1]
C0033774
Pain
Beschreibung

Pain

Datentyp

text

Alias
UMLS CUI [1]
C0030193
Total Score
Beschreibung

Total Score

Datentyp

integer

Alias
UMLS CUI [1,1]
C2964552
UMLS CUI [1,2]
C0681889
UMLS CUI [1,3]
C0037278
Culture Results for Nasal Swab (NASAL)
Beschreibung

Culture Results for Nasal Swab (NASAL)

Was there any growth after 2 days?
Beschreibung

Was there any growth after 2 days?

Datentyp

text

Alias
UMLS CUI [1,1]
C0879240
UMLS CUI [1,2]
C2061903
If "yes", please specify:
Beschreibung

If

Datentyp

text

Alias
UMLS CUI [1]
C2061903
Pathogen Isolation for Nasal Swab (NASAL_P)
Beschreibung

Pathogen Isolation for Nasal Swab (NASAL_P)

Isolate number
Beschreibung

Isolate number

Datentyp

integer

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

Quantitation

Datentyp

text

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

Identification

Datentyp

text

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

If "other", specify:

Datentyp

text

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

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

Datentyp

text

If "no", specify reason:
Beschreibung

If "no", specify reason:

Datentyp

text

Alias
UMLS CUI [1]
C0392360
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Ähnliche Modelle

SIRS & Nasal swab Topical SB-275833 Ointment 1% For The Treatment Of Impetigo NCT00133874

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Skin Infection Rating Scale
Instructions for rating
Item
Instructions for rating
text
Item
Exsudate/Pus
text
C0015388 (UMLS CUI [1])
C0034161 (UMLS CUI [2])
Exsudate/Pus
Code List
Exsudate/Pus
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Item
Crusting
text
C0205204 (UMLS CUI [1])
Crusting
Code List
Crusting
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Item
Erythema/Inflammation
text
C0041834 (UMLS CUI [1])
C0021368 (UMLS CUI [2])
Erythema/Inflammation
Code List
Erythema/Inflammation
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Item
Tissue warmth
text
C2184256 (UMLS CUI [1])
Tissue warmth
Code List
Tissue warmth
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Item
Tissue oedema
text
C0013604 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
Tissue oedema
Code List
Tissue oedema
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Item
Itching
text
C0033774 (UMLS CUI [1])
Itching
Code List
Itching
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Item
Pain
text
C0030193 (UMLS CUI [1])
Pain
Code List
Pain
CL Item
0; Absent (0)
CL Item
1 (1)
CL Item
2; Mild (2)
CL Item
3 (3)
CL Item
4; Moderate (4)
CL Item
5 (5)
CL Item
6; Severe (6)
Total Score
Item
Total Score
integer
C2964552 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0037278 (UMLS CUI [1,3])
Item Group
Culture Results for Nasal Swab (NASAL)
Item
Was there any growth after 2 days?
text
C0879240 (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 "yes", please specify:
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 Nasal Swab (NASAL_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])
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