Clostridium Enterocolitis, Diarrhea
Conditions
Keywords
Pseudomembranous Colitis, Clostridium difficile-associated diarrhea, C. difficile, CDAD
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.
Interventions
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of diarrhea | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of diarrhea | — |
| Recurrence rate | — |
| Number of stools | — |
| Average stool consistency | — |
| Treatment success | — |
Countries
Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed