Conditions: Clostridium Infections Diarrhea
Keywords: CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 629
Healthy volunteers: no

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 description:
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.

Arms:
arm 1: Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \[q12h\] regimen) with intermittent matching placebo to fidaxomicin arm 2: Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).

Interventions: intervention 1: Fidaxomicin intervention 2: Vancomycin intervention 3: Matching Placebo to Fidaxomicin
Intervention descriptions: intervention 1: 200 mg oral capsules two times daily (q12h regimen) intervention 2: 125 mg capsules q6hr (4 times a day) intervention 3: Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

Protocol document: