A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
- Conditions
- Recurrent C. Difficile Infection
- Interventions
- Biological: CP101Other: Placebo
- Registration Number
- NCT05153499
- Lead Sponsor
- Finch Research and Development LLC.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CP101 CP101 - Placebo Placebo -
- 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.
Trial Locations
- Locations (67)
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Brody School of Medicine at ECU
🇺🇸Greenville, North Carolina, United States
1960 Family Practice P.A.
🇺🇸Houston, Texas, United States
Pinehurst Medical Clinic Inc
🇺🇸Pinehurst, North Carolina, United States
TruCare Internal Medicine & Infectious Diseases
🇺🇸DuBois, Pennsylvania, United States
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada
MedPharmics LLC
🇺🇸Gulfport, Mississippi, United States
Medical Research Center of Connecticut LLC
🇺🇸Hamden, Connecticut, United States
ENCORE Borland-Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
Snake River Research, PLLC
🇺🇸Idaho Falls, Idaho, United States
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
George Washington University School of Medicine and Health
🇺🇸Washington, District of Columbia, United States
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
Theia Clinical Research, LLC
🇺🇸Saint Petersburg, Florida, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Metro Infectious Disease Consultants
🇺🇸Burr Ridge, Illinois, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Regional GI
🇺🇸Lancaster, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Guthrie Clinic
🇺🇸Sayre, Pennsylvania, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
CARe Clinic
🇨🇦Red Deer, Alberta, Canada
Main Street Physicians Care
🇺🇸Loris, South Carolina, United States
Christiana Care Health System
🇺🇸Newark, Delaware, United States
Kelsey Seybold Clinic
🇺🇸Houston, Texas, United States
University of Calgary - Calgary Health Region
🇨🇦Calgary, Alberta, Canada
Infectious Diseases Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
Yazdan Medical Corporation
🇨🇦Vancouver, British Columbia, Canada
Saint Joseph's Health Care London
🇨🇦London, Ontario, Canada
San Marcus Research Clinic Inc
🇺🇸Miami, Florida, United States
Gastro Health LLC
🇺🇸Cincinnati, Ohio, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Reliant Medical Research
🇺🇸Miami, Florida, United States
St Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
Southern Star Research Institute LLC
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Stanford Healthcare
🇺🇸Stanford, California, 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
Guardian Angel Research
🇺🇸Tampa, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Iowa Clinic
🇺🇸Des Moines, Iowa, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
William Beaumont Hospital
🇺🇸Farmington Hills, Michigan, United States
St. Charles Clinical Research, LLC
🇺🇸Weldon Spring, Missouri, United States
North Shore University Hospital-(Manhasset)
🇺🇸Manhasset, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Digiovanna Institute For Medical Education and Research
🇺🇸North Massapequa, New York, United States
Central New York Research Corporation
🇺🇸Syracuse, New York, United States
Women's Medicine Collaborative
🇺🇸Providence, Rhode Island, United States
Digestive Health Associates of Texas, PA
🇺🇸Carrollton, Texas, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Lowcountry Infectious Diseases PA
🇺🇸Charleston, South Carolina, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States