Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Condition: Clostridium Difficile Infection; Recurrent Clostridium Difficile Infection; C. Diff; CDI; Recurrent C. Diff; rCDI; C. Difficile; Recurrent CDI; FMT; Fecal Microbiota; Fecal Transplant
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Recurrence
Intervention: CP101
Intervention description: Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium Difficile Infection; CP101; Crestovo; FMT; CDI; C. difficile; C. diff; Recurrent Clostridium Difficile Infection; Recurrent C. diff; Recurrent CDI; Finch; Fecal transplant; Fecal microbiota transplant; rCDI; Finch Therapeutics

Summary:

      This 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.
    

Eligibility criteria:

        1. Ability to provide written informed consent;

          2. 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

          3. An outpatient prior to Treatment

          4. 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:

          1. Pregnant, breast-feeding, or considering becoming pregnant during the study

          2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's
             disease and ulcerative colitis)

          3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome

          4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days
             prior to consent or planned during the 8 weeks following Randomization

          5. Prior fecal transplant for any condition, regardless of route of administration in the
             last year or plans to undergo during the study

          6. Major intra-abdominal surgery within the past 60 days prior to Screening

          7. 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

          8. History of total colectomy/ileostomy or bariatric surgery

          9. Planned hospitalization or invasive surgery during the study

         10. Severe acute illness unrelated to CDI