A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
NCT ID: NCT05153499
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
19 participants
INTERVENTIONAL
2021-11-15
2023-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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CP101
CP101
CP101 is an investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent Clostridioides difficile infection (CDI).
Placebo
Placebo
Placebo
Interventions
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CP101
CP101 is an investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent Clostridioides difficile infection (CDI).
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Finch Research and Development LLC.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, 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
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
Loyola University Medical Center
Maywood, Illinois, United States
Iowa Clinic
Des Moines, Iowa, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
William Beaumont Hospital
Farmington Hills, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
MedPharmics LLC
Gulfport, Mississippi, United States
St. Charles Clinical Research, LLC
Weldon Spring, Missouri, United States
Mercury Street Medical Group
Butte, Montana, United States
North Shore University Hospital-(Manhasset)
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Weill Cornell Medicine
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
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Brody School of Medicine at ECU
Greenville, North Carolina, United States
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Gastro Health LLC
Cincinnati, Ohio, United States
TruCare Internal Medicine & Infectious Diseases
DuBois, Pennsylvania, United States
Regional GI
Lancaster, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Guthrie Clinic
Sayre, Pennsylvania, United States
Women's Medicine Collaborative
Providence, Rhode Island, United States
Lowcountry Infectious Diseases PA
Charleston, South Carolina, United States
Main Street Physicians Care
Loris, South Carolina, United States
Digestive Health Associates of Texas, PA
Carrollton, Texas, United States
Kelsey Seybold Clinic
Houston, Texas, United States
1960 Family Practice P.A.
Houston, Texas, United States
Southern Star Research Institute LLC
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, United States
University of Calgary - Calgary Health Region
Calgary, Alberta, Canada
CARe Clinic
Red Deer, Alberta, Canada
Yazdan Medical Corporation
Vancouver, British Columbia, Canada
Vancouver Island Health Authority
Victoria, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Saint Joseph's Health Care London
London, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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FIN-CDI-301
Identifier Type: -
Identifier Source: org_study_id
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