Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
United States793 participantsStarted 2019-07-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years old.
✓. Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
✓. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. \[Note: Subject's CDI diarrhea must be controlled (\<3 unformed/loose stools/day) while taking antibiotics during screening.\]
Exclusion criteria
✕. Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
✕. Requires systemic antibiotic therapy for a condition other than CDI.
✕. Fecal microbiota transplant (FMT) within the past 6 months.
✕. FMT with an associated serious adverse event related to the FMT product or procedure.
✕. Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
What they're measuring
1
Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.
Timeframe: Up to 6 months after last study treatment.