At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection
In Brief
A Phase 3 clinical trial evaluating RBX2660, Placebo, and 1 other intervention for Clostridium Difficile Infection (CDI). Completed, enrolled 320 participants across 66 sites in 2 countries.
Detailed Summary
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.
Study Details
Timeline
Interventions
RBX2660 is a rectally administered microbiota suspension
Placebo is normal saline solution administered rectally
RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660