Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II. (28th December 2019)

• Record Type: Journal Article
• Authors: Goldstein, Ellie J C; Citron, Diane M; Gerding, Dale N; Wilcox, Mark H; Gabryelski, Lori; Pedley, Alison; Zeng, Zhen; Dorr, Mary Beth
• Is Part Of: Clinical infectious diseases. Volume 71:Number 4(2020)
• Page Start: 1102
• Page End: 1105
• Publication Date: 2019-12-28
• Subjects: bezlotoxumab -- Clostridioides difficile -- recurrence -- extension phase; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciz1151
• Languages: English
• ISSNs: 1058-4838

Abstract

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.