In a recent multicenter, double-blind, randomized, non-inferiority trial, vancomycin was compared to fidaxomixin for Clostridium difficile infection.
Location: 45 sites in Europe and 41 sites in the USA and Canada
Patients: Age 16 years or older with acute toxin-positive C difficile infection.
Treatment: Oral fidaxomicin (200 mg every 12 h) or oral vancomycin (125 mg every 6 h) for 10 days.
Endpoint: Clinical cure, defined as resolution of diarrhea and no further need for treatment.
Results: 198 (91.7%) of 216 patients in the per-protocol population given fidaxomicin achieved clinical cure, compared with 213 (90.6%) of 235 given vancomycin (one-sided 97·5% CI -4·3%). Occurrence of treatment-emergent adverse events did not differ between groups.
Author conclusions: Fidaxomicin could be an alternative treatment for infection with C difficile, with similar efficacy and safety to vancomycin.
Funding: Optimer Pharmaceuticals.
References
Cornely OA, Crook DW, Esposito R, et al. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis 2012 Apr;12(4):281-9.
