Fidaxomicin Versus Vancomycin for Clostridium dif fi cile Infection: Meta-analysis of Pivotal Randomized Controlled Trials for the Study 003/004 Teams

Two recently completed phase 3 trials (003 and 004) showed fi daxomicin to be noninferior to vancomycin for curing Clostridium dif fi cile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fi daxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fi xed-effects

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