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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Recurrent C. Difficile Infection

In brief

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.

Key facts

Study ID

NCT05153499

Run by

Finch Research and Development LLC.

People needed

19

Starts

2021-11-15

Expected to finish

2023-02-24

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• George Washington University School of Medicine and Health — Washington D.C., District of Columbia, United States
• University of Florida Health — Gainesville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• ENCORE Borland-Groover Clinical Research — Jacksonville, Florida, United States
• San Marcus Research Clinic Inc — Miami, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Reliant Medical Research — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Theia Clinical Research, LLC — St. Petersburg, Florida, United States
• Guardian Angel Research — Tampa, Florida, United States
• St Joseph's Comprehensive Research Institute — Tampa, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Snake River Research, PLLC — Idaho Falls, Idaho, United States
• Metro Infectious Disease Consultants — Burr Ridge, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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