Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II

Clin Infect Dis. 2020 Aug 14;71(4):1102-1105. doi: 10.1093/cid/ciz1151.

Abstract

From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34). Bezlotoxumab's efficacy appears to be due to prevention rather than delayed onset of rCDI. Clinical Trials Registration. NCT01513239.

Keywords: Clostridioides difficile; bezlotoxumab; extension phase; recurrence.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • Antibodies, Monoclonal / therapeutic use
  • Broadly Neutralizing Antibodies
  • Clostridioides
  • Clostridioides difficile*
  • Clostridium Infections* / drug therapy
  • Clostridium Infections* / prevention & control
  • Humans
  • Recurrence

Substances

  • Anti-Bacterial Agents
  • Antibodies, Monoclonal
  • Broadly Neutralizing Antibodies
  • bezlotoxumab

Associated data

  • ClinicalTrials.gov/NCT01513239