Conditions: Clostridium Infections Diarrhea
Keywords: CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 535
Healthy volunteers: no

Brief summary:
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Detailed description:
The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 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.

Arms:
arm 1: Vancomycin arm 2: PAR-101/OPT-80

Interventions: intervention 1: PAR-101/OPT-80 intervention 2: Vancomycin
Intervention descriptions: intervention 1: capsules intervention 2: Capsules

Protocol document: