CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 793 enrolled
Drug / intervention
RBX2660drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03931941
NCT03931941Phase 3Completed
CompareCT.gov

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection

Rebiotix Inc.·interventional·Posted Apr 30, 2019·Updated Aug 7, 2024

In Brief

A Phase 3 clinical trial evaluating RBX2660 for Clostridium Difficile Infection and 2 related conditions. Completed, enrolled 793 participants across 51 sites in 2 countries.

Detailed Summary

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI 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 CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection, Infection, Communicable Diseases
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 30, 2019
Enrollment StartJul 30, 2019
Primary CompletionJul 21, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.2 years ago

Interventions

RBX2660drug

RBX2660 is a microbiota suspension administered as an enema