Clinical Trial: Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects
Brief Summary: This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
Detailed Summary: 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.
Sponsor: Optimer Pharmaceuticals LLC
Current Primary Outcome: Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ]
Original Primary Outcome: Cure Rate at End of Therapy
Current Secondary Outcome: Recurrence [ Time Frame: Study days 11-40 ]
Original Secondary Outcome: Recurrence rate
Information By: Optimer Pharmaceuticals LLC
Dates:
Date Received: April 13, 2006
Date Started: May 2, 2006
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017