Analysis of C. difficile infection–related outcomes in European participants in the bezlotoxumab MODIFY I and II trials

• DOI: 10.1007/s10096-020-03935-3
• Publication Date: 2020-07-08T10:03:43Z
• Authors: Emilio Bouza; Oliver A. Cornely; Antonio Ramos-Mar...; Robert Plesniak; Misoo C. Ellison; Mary E. Hanson; Mary Beth Dorr
• Keywords: Clostridioides; Placebo group

Abstract The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for infection (CDI) significantly reduced C. recurrence (rCDI) in adults at high risk rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy bezlotoxumab subgroup trial participants enrolled Europe. Data from (10 mg/kg single intravenous infusion) placebo (0.9% saline) groups were compared to assess initial clinical cure (ICC), rCDI, all-cause, CDI-associated rehospitalizations within 30 days discharge, mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 Europe (bezlotoxumab n = 313, 51%; 292; 48%). Baseline characteristics generally similar across groups, although there more immunocompromised group (27.2%) with (20.1%). Fifty-five percent female, 86% hospitalized randomization. rate ICC was between groups. rCDI lower among European overall, those ≥ 1 factor Bezlotoxumab 30-day placebo. These results are consistent overall demonstrate reduces patients CDI. (NCT01241552 NCT01513239)