Phase 3
N=698
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
Clostridium Difficile Infection · Infection · Communicable Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03931941 ↗Enrolled (actual)
698
Serious AEs
12.5%
Results posted
Aug 2024
Primary outcome: Primary: Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI. — 697 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RBX2660 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rebiotix Inc.
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI. |
697 | — |
| SECONDARY Efficacy of RBX2660 Measured at 8 Weeks After Treatment. |
499 | — |
| SECONDARY Sustained Clinical Response Through 6 Months After Treatment. |
454 | — |
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.
Eligibility Criteria
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.
- CD4 count <200/mm^3 during Screening.
- An absolute neutrophil count of <1000 cells/µL during Screening.
- Pregnant, breastfeeding, or intends to become pregnant during study participation.
Data sourced from ClinicalTrials.gov (NCT03931941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.