Status:
COMPLETED
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Lead Sponsor:
Rebiotix Inc.
Conditions:
Clostridium Difficile Infection (CDI)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) effic...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2020
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03244644
Start Date
July 31 2017
End Date
August 3 2020
Last Update
July 10 2024
Active Locations (66)
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1
Athens
Athens, Alabama, United States, 35611
2
Dothan
Dothan, Alabama, United States, 36305
3
Phoenix
Phoenix, Arizona, United States, 85054
4
North Little Rock
North Little Rock, Arkansas, United States, 72117