A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)

Phase 3

Terminated

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Sustained Clinical Cure Through Week 8	Week 8	No data displayed because Outcome Measure has zero participants analyzed.

Secondary Outcome Measures

Name	Time	Method
Sustained Clinical Cure Through Week 24	Week 24	No data displayed because Outcome Measure has zero participants analyzed.
CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture	Week 24	No data displayed because Outcome Measure has zero participants analyzed.

Locations (67): Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Facey Medical Foundation
🇺🇸
Mission Hills, California, United States
Kaiser Permanente Division of Research
🇺🇸
Oakland, California, United States
UCSF
🇺🇸
San Francisco, California, United States
Stanford Healthcare
🇺🇸
Stanford, California, United States
University of Colorado School of Medicine
🇺🇸
Aurora, Colorado, United States
Bridgeport Hospital
🇺🇸
Bridgeport, Connecticut, United States
Medical Research Center of Connecticut LLC
🇺🇸
Hamden, Connecticut, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Christiana Care Health System
🇺🇸
Newark, Delaware, United States
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Mayo Clinic
🇺🇸Rochester, Minnesota, United States