Conditions: Clostridium Difficile Infection
Keywords: CDAD Clostridium difficile Associated Diarrhea CDI Clostridium difficile Infection Diarrhea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 608
Healthy volunteers: no

Brief summary:
A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

Detailed description:

Arms:
arm 1: Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days. arm 2: Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.

Interventions: intervention 1: CB-183,315 intervention 2: Vancomycin intervention 3: Placebo
Intervention descriptions: intervention 1: CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule. intervention 2: Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule. intervention 3: Placebo size 00 opaque hard gelatin capsules.

Protocol document: