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

Genzyme, a Sanofi Company520 enrolled

Overview

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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. Total length of participation is approximately 6 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

520

Conditions

Clostridium Enterocolitis Pseudomembranous Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age * 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 a 6 week study period

Locations (140)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Rogers, Arkansas, United States

Unnamed facility

Burbank, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Resolution of diarrhea

Secondary Outcomes

Time to resolution of diarrhea

Recurrence rate

Number of stools

Average stool consistency

Treatment success