Results from a Randomized, Placebo-Controlled Clinical Trial of a RBX2660 - A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection

Erik R. Dubberke, Christine H. Lee, Robert Orenstein, Sahil Khanna, Gail Hecht, Dale N. Gerding

Research output: Contribution to journalArticlepeer-review

64 Scopus citations

Abstract

Background Despite advancements, recurrent Clostridium difficile infections (CDI) remain an urgent public health threat with insufficient response rates to currently approved antibiotic therapies. Microbiota-based treatments appear effective, but rigorous clinical trials are required to optimize dosing strategies and substantiate long-term safety. Methods This randomized, double-blind, placebo-controlled phase 2B trial enrolled adults with 2 or more CDI recurrences to receive: 2 doses of RBX2660, a standardized microbiota-based drug (group A); 2doses of placebo (group B); or 1 dose of RBX2660 followed by 1 dose of placebo (group C). Efficacy was defined as prevention of recurrent CDI for 8 weeks following treatment. Participants who had a recurrence within 8 weeks were eligible to receive up to 2 open-label RBX2660 doses. The primary endpoint was efficacy for group A compared to group B. Secondary endpoints included the efficacy of group C compared to group B, combined efficacy in the blinded and open-label phases, and safety for 24 months. Results The efficacy for groups A, B, and C were 61%, 45%, and 67%, respectively. The primary endpoint was not met (P =.152). One RBX2660 dose (group C) was superior to placebo (group B; P =.048), and the overall efficacy (including open-label response) for RBX2660-treated participants was 88.8%. Adverse events did not differ significantly among treatment groups. Conclusions One, but not 2, doses of RBX2660 was superior to placebo in this randomized, placebo-controlled trial. These data provide important insights for a larger phase 3 trial and continued clinical development of RBX2660. Clinical Trials Registration NCT02299570.

Original languageEnglish
Pages (from-to)1198-1204
Number of pages7
JournalClinical Infectious Diseases
Volume67
Issue number8
DOIs
StatePublished - Sep 28 2018

Keywords

  • Clostridium difficile infection
  • clinical trial
  • microbiota-based therapy
  • placebo
  • recurrence

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