Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
- Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ] [ Designated as safety issue: No ]Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
- Recurrence [ Time Frame: Study days 11-40 ] [ Designated as safety issue: No ]Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.
- Global Cure [ Time Frame: End of Study (Day 40) ] [ Designated as safety issue: No ]Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.
|Study Start Date:||May 2006|
|Study Completion Date:||August 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: vancomycin||
125 mg capsules q6hr (4 times a day)
200 mg capsules q12hr (2 times a day)
The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314951
Show 58 Study Locations
|Study Director:||Dr. Sherwood Gorbach, MD||Optimer Pharmaceuticals, Inc.|