NCT05153499TerminatedPhase 3
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.132 sites in 1 country19 target enrollmentStarted: November 15, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 19
- Locations
- 132
- Primary Endpoint
- Sustained Clinical Cure Through Week 8
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)
Investigators
Study Sites (132)
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