Conditions: Clostridium Difficile Infection
Keywords: CDAD Clostridium difficile Associated Diarrhea CDI Clostridium difficile Infection Diarrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief summary:
606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.

Detailed description:

Arms:
arm 1: 250 mg Surotomycin over- encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days arm 2: 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days

Interventions: intervention 1: Surotomycin intervention 2: Vancomycin intervention 3: Placebo
Intervention descriptions: intervention 1: 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days intervention 2: 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days intervention 3: Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days

Protocol document: