Study of CB-183,315 in Participants With Clostridium Difficile Infection
Status:
Completed
Trial end date:
2011-05-13
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel
group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared
with the active comparator oral vancomycin (125 milligrams (mg ) four times daily).
Participants with diarrhea at risk for Clostridium difficile infection (CDI) [for example,
received prior or concomitant antibiotic(s)] will be identified and tested for C. difficile
toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the
usual standard of care. Eligible participants will be consented, undergo baseline
evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms.
Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating
with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo
tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a
1:1:1 fashion.