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 (CDI)

Finch Research and Development LLC.67 sites in 1 country19 target enrollmentNovember 15, 2021

ConditionsRecurrent C. Difficile Infection

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Recurrent C. Difficile Infection
Sponsor: Finch Research and Development LLC.
Enrollment: 19
Locations: 67
Primary Endpoint: Sustained Clinical Cure Through Week 8
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2021

End Date

February 24, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Finch Research and Development LLC.

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

Sustained Clinical Cure Through Week 8

Time Frame: Week 8

No data displayed because Outcome Measure has zero participants analyzed.

Secondary Outcomes

Sustained Clinical Cure Through Week 24(Week 24)
CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture(Week 24)