A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
Condition: Recurrent C. Difficile Infection
MeSH terms: Infections; Communicable Diseases; Recurrence
Intervention: CP101; Placebo
Intervention description: CP101 is an investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent Clostridioides difficile infection (CDI).; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: C. difficile infection; recurrent Clostridium difficile infection; Clostriodioides difficile infection; recurrent C. diff infection; multiple recurrent C. diff infection; CDI; c. diff; microbiota transplantation; FMT; Fecal microbiota transplantation; Fecal microbiota transplant; Fecal transplant

Summary:

      This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy,
      Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of
      Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted
      in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional
      open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their
      most recent CDI recurrence, patients who meet all eligibility requirements will be randomized
      in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI
      recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week
      24. Patients who qualify may enroll into the optional open label arm if they experience CDI
      recurrence through week 8.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent

          -  Men or women over 18 years of age or older

          -  Current diagnosis of a recurrence of non-severe, non-complicated CDI

          -  Subject has a clinical response to standard-of-care CDI antibiotics for the most
             recent CDI episode

          -  History of recurrent CDI defined as:

               -  ≥ 3 episodes of CDI, with 2 episodes occurring within the previous 6 months
                  (inclusive of the current episode); OR

               -  Patients with a history of 2 episodes of CDI occurring within the previous 6
                  months (inclusive of the current episode) may be eligible if 65 years of age or
                  older.

          -  For the Qualifying CDI episode, the following criteria must be satisfied:

               -  History of diarrhea (> 3 unformed stools per day) for 2 or more consecutive days
                  that is clinically consistent with CDI. AND

               -  Documented positive stool test by local laboratory for toxigenic C. difficile
                  (toxin enzyme immunoassay [EIA] or polymerase chain reaction [PCR]-based testing)
                  for the current CDI episode and within 45 days prior to Randomization. AND

               -  Received a course of SOC CDI antibiotics for the most recent CDI episode (for 10
                  to 21 days, with exact duration, antibiotic type, and dose at the discretion of
                  the Investigator). AND

               -  Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24
                  hours for 2 or more consecutive days during SOC CDI antibiotics prior to
                  Randomization.

        Exclusion Criteria:

          -  Known stool sample testing positive for enteric pathogen(s) (e.g., Salmonella,
             Shigella, diarrhoeagenic E. coli, Campylobacter, Giardia) within 28 days prior to
             Screening

          -  Pregnant, breast-feeding, or planning to become pregnant during the trial

          -  Historical or current diagnosis of inflammatory bowel disease

          -  Recent diagnosis (<6 months prior to screening) of diarrhea-predominant irritable
             bowel syndrome (post-infection or non-related to an enteric infection)

          -  Initiation of any systemic cancer treatment (e.g., chemotherapy, radiotherapy,
             biologic, immunotherapy, others) for active malignancy

          -  Major intra-abdominal surgery (e.g., bowel resection)

          -  Known primary or secondary immunodeficiency