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

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.

Timeline

Start

2021-11-15

Primary completion

2023-02-24

Completion

2023-02-24

Outcome

Outcome not reported

Stopped (Business): “The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor.”

Drugs

Indications