Clinical trial NCT00196794: A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Official title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Enterocolitis
Diarrhea
Keywords: Pseudomembranous Colitis
Clostridium difficile-associated diarrhea
C. difficile
CDAD
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and above
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete 6 week study period.

Primary outcomes:
measure: Resolution of diarrhea
Secondary outcomes:
measure: Time to resolution of diarrhea
measure: Recurrence rate
measure: Number of stools
measure: Average stool consistency
measure: Treatment success
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Bedford Park
country: Australia
city: Cairns
country: Australia
city: Concord
country: Australia
city: Darlinghurst
country: Australia
city: Five Dock
country: Australia
city: Footscray
country: Australia
city: Herston
country: Australia
city: Hobart
country: Australia
city: Kogarah
country: Australia
city: Nambour
country: Australia
city: Nedlands
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Randwick
country: Australia
city: South Brisbane
country: Australia
city: Southport
country: Australia
city: Woolloongabba
country: Australia
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Linz
country: Austria
city: Oberndorf
country: Austria
city: Salzburg
country: Austria
city: Aalst
country: Belgium
city: Braine L'Alleud
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Yvoir
country: Belgium
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Melnik
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Copenhagen
country: Denmark
city: Copenhagen
country: Denmark
city: Herlev
country: Denmark
city: Hvidovre
country: Denmark
city: Amiens
country: France
city: Annecy
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Garches
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Saint Etienne
country: France
city: Tourcoing
country: France
city: Vandoeuvre-les-Nancy
country: France
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Frankfurt
country: Germany
city: Frankfurt
country: Germany
city: Greifswald
country: Germany
city: Hannover
country: Germany
city: Hofheim
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Lübeck
country: Germany
city: Regensburg
country: Germany
city: Wilhelmshaven
country: Germany
city: Castlebar
country: Ireland
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Bergen
country: Norway
city: Bergen
country: Norway
city: Bodo
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Tonsberg
country: Norway
city: Tromso
country: Norway
city: Trondheim
country: Norway
city: Carnaxide
country: Portugal
city: Coimbra
country: Portugal
city: Matosinhos
country: Portugal
city: Porto
country: Portugal
city: Alcala de Henares
country: Spain
city: Badalona
country: Spain
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: El Palmar-Murcia
country: Spain
city: Guadalajara
country: Spain
city: Leganes
country: Spain
city: Lleida
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: San Sebastian
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Terrassa
country: Spain
city: Goteborg
country: Sweden
city: Joenkoeping
country: Sweden
city: Kalmar
country: Sweden
city: Karlskrona
country: Sweden
city: Kristianstad
country: Sweden
city: Lund
country: Sweden
city: Malmö
country: Sweden
city: Oerebro
country: Sweden
city: Skoevde
country: Sweden
city: Baden
country: Switzerland
city: Basel
country: Switzerland
city: Bellinzona
country: Switzerland
city: Geneva
country: Switzerland
city: Lugano
country: Switzerland
city: Abergavenny
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Bury
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Gwent
country: United Kingdom
city: Ipswich
country: United Kingdom
city: Keighley
country: United Kingdom
city: Leeds
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stockport
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Winchester
country: United Kingdom
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.