drugset
drugset / Trial / NCT03931941

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

NCT03931941 ↗

Phase 3 Completed 793 enrolled Rebiotix Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-07-30
Primary completion
2023-07-21
Completion
2023-07-21

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject RBX2660 Other / unclassified — Rectal

Indications

Clostridium difficile colitis