Phase 3
N=267
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Clostridium Difficile Infection (CDI)
Bottom Line
View on ClinicalTrials.gov: NCT03244644 ↗Enrolled (actual)
267
Serious AEs
7.2%
Results posted
Aug 2023
Primary outcome: Primary: Efficacy of RBX2660 Compared to Placebo Through 8 Weeks — 57.5; 70.6 Model-estimated percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RBX2660 (Drug); Placebo (Drug); Open label RBX2660 (only for confirmed CDI recurrence) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rebiotix Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of RBX2660 Compared to Placebo Through 8 Weeks |
57.5; 70.6 | — |
| SECONDARY Sustained Clinical Response Through 6 Months After Blinded Treatment |
48; 116; 48; 116 | 0.156 |
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.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years old.
- Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
- A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
- 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 this course of antibiotics]
Exclusion Criteria
- Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
- Previous fecal transplant
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
- Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
- 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 (NCT03244644). 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.