6/28/23, 10:41 PM Fidaxomicin for C. difficile colitis Pathway Feedback Search Clinical Topics Home Studies Fidaxomicin for C. difficile colitis Fidaxomicin for C. difficile colitis Disease Clostridioides difficile infection Trial question Is fidaxomicin noninferior to vancomycin in patients with acute C. difficile infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.8% female N = 629 44.2% male 629 patients (333 female, 263 male) Inclusion criteria: adults with acute symptoms of C. difficile infection and a positive result on a stool toxin test Key exclusion criteria: life-threatening or fulminant C. difficile infection, toxic megacolon, previous exposure to fidaxomicin, history of ulcerative colitis or Crohn's disease, or > 1 occurrence of C. difficile infection within 3 months before the start of the study Interventions N=302 fidaxomicin (200 mg BID PO for 10 days) N=327 vancomycin (125 mg QID PO for 10 days) Primary outcome Recurrence of infection 25.3 % 25.3 https://web.pathway.md/studies/recMkAXIOKqIliDcC 1/2 6/28/23, 10:41 PM Fidaxomicin for C. difficile colitis Pathway 19.0 % 15.4 12.7 % Significant increase 6.3 % NNH = 10 0.0 % Fidaxomicin Vancomycin Significant increase in recurrence of infection (15.4% vs. 25.3%; ARR 9.9, 95% CI -16.6 to -2.9) Secondary outcomes Significant increase in resolution of diarrhea without recurrence (74.6% vs. 64.1%; ARD 10.5, 95% CI 3.1 to 17.7) Safety outcomes No significant difference in adverse events. Conclusion In adults with acute symptoms of C. difficile infection and a positive result on a stool toxin test, fidaxomicin was noninferior to vancomycin with respect to recurrence of infection. Reference Louie TJ, Miller MA, Mullane KM et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011 Feb 3;364(5):422-31. Open reference URL https://web.pathway.md/studies/recMkAXIOKqIliDcC 2/2