Title: Fidaxomicin versus Vancomycin for Clostridium difficile Infection Clinical trial

Design: Prospective, multicenter, double-blind, randomized, parallel-group trial

Objective: To assess the non-inferiority of fidaxomicin to vancomycin in curing patients with Clostridium difficile-associated diarrhea

N=629

Year of publication: 2011

Inclusion Criteria: Patients with diarrhea positive for C. difficile toxin within 48h prior to randomization

Comparison groups: Fidaxomicin 200mg PO q12h with intervening doses of placebo (n=302) vs Vancomycin 125mg PO q6h (n=327)

Primary Outcome:

  • Clinical cure 88.2% vs 85.8%

Secondary Outcome:

  • Recurrence 9.9% points; 95% CI, ?16.6 to ?2.9; 15.4% vs 25.3% P=0.005

Conclusion: The rates of clinical cure after treatment with fidaxomicin were noninferior to those after treatment with vancomycin. Fidaxomicin was associated with a significantly lower rate of recurrence of C. difficile infection

Source: Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364(5):422-31.