Title
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Phase
Phase 2Lead Sponsor
Finch Research and Development LLC.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Recurrent Clostridium Difficile Infection CDI Recurrent C. Diff C. Diff rCDI C. Difficile Recurrent CDI FMT Fecal Microbiota ...Intervention/Treatment
CP101Study Participants
132This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101.
Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program.
Ability to provide written informed consent; Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI An outpatient prior to Treatment Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period. Exclusion Criteria: Pregnant, breast-feeding, or considering becoming pregnant during the study Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) Any prior diagnosis of diarrhea-predominant irritable bowel syndrome Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study Major intra-abdominal surgery within the past 60 days prior to Screening Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry History of total colectomy/ileostomy or bariatric surgery Planned hospitalization or invasive surgery during the study Severe acute illness unrelated to CDI
| Event Type | Organ System | Event Term | CP101 |
|---|
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
