A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

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.

Official Title

A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea

Conditions

Clostridium Enterocolitis, Diarrhea

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Resolution of diarrhea

Secondary Outcome Measures:

• Time to resolution of diarrhea
• Recurrence rate
• Number of stools
• Average stool consistency
• Treatment success

Study Start

April 2005; Study completion: August 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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.

Total Enrolment

520

Contact Details

Australian Locations:

• Herston, 4032, Australia
• Five Dock, 2046, Australia
• Footscray, 3011, Australia
• Randwick, 2031, Australia
• Perth, 6000, Australia
• South Brisbane, 4101, Australia
• Nedlands, 6009, Australia
• Bedford Park, 5042, Australia
• Darlinghurst, 2010, Australia
• Concord, 2139, Australia
• Kogarah, 2217, Australia
• Parkville, 3050, Australia
• Hobart, 7000, Australia
• St. Leonards, 2065, Australia
• Southport, 4215, Australia
• Adelaide, 5000, Australia
• Nambour, 4560, Australia
• Cairns, 4870, Australia
• Woolloongabba, 4102, Australia

For more information, see Genzyme Clinical research