UMEM Educational Pearls

Category: Pharmacology & Therapeutics

Title: Fidaxomicin vs. Vancomycin for Clostridium difficile infection

Keywords: vancomycin, c. diff, clostridium difficile, fidaxomicin (PubMed Search)

Posted: 4/4/2012 by Bryan Hayes, PharmD (Emailed: 4/7/2012) (Updated: 4/7/2012)
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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.


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.

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