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

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)

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 Overview

• Status: Terminated
• Conditions: Recurrent C. Difficile Infection
• Intervention / Treatment: Other: Placebo; Biological: CP101

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: World Reach Global Access; Phone Number: 25347 877-223-3576; Email: FinchCTHotline@druginfo.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary - Calgary Health Region
    • Red Deer, Alberta, Canada, T4P 1K4
      • Care Clinic
  • British Columbia
    • Vancouver, British Columbia, Canada, V7M 1Z8
      • Yazdan Medical Corporation
    • Victoria, British Columbia, Canada, V8R 1J8
      • Vancouver Island Health Authority
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4R2
      • Dalhousie University
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Saint Joseph's Health Care London
    • Toronto, Ontario, Canada, M5G 1L7
      • University Health Network
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Oakland, California, United States, 94611
      • Kaiser Permanente Division of Research
    • San Francisco, California, United States, 94143
      • UCSF
    • Stanford, California, United States, 94305
      • Stanford Healthcare
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut LLC
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University School of Medicine and Health
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Jacksonville, Florida, United States, 32256
      • Encore Borland-Groover Clinical Research
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center
    • Miami, Florida, United States, 33014
      • San Marcus Research Clinic Inc
    • Miami, Florida, United States, 33165
      • Reliant Medical Research
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Saint Petersburg, Florida, United States, 33709
      • Theia Clinical Research, LLC
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research
    • Tampa, Florida, United States, 33614
      • St Joseph's Comprehensive Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research, PLLC
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Metro Infectious Disease Consultants
    • Evanston, Illinois, United States, 60077
      • Northshore University Healthsystem
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • Iowa Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • William Beaumont Hospital
    • Novi, Michigan, United States, 48377
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • MedPharmics LLC
  • Missouri
    • Weldon Spring, Missouri, United States, 63304
      • St. Charles Clinical Research, LLC
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital-(Manhasset)
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education And Research
    • Syracuse, New York, United States, 13210
      • Central New York Research Corporation
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Greenville, North Carolina, United States, 27834
      • Brody School of Medicine at ECU
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Clinic Inc
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Gastro Health LLC
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • TruCare Internal Medicine & Infectious Diseases
    • Lancaster, Pennsylvania, United States, 17601
      • Regional GI
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinic
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Women's Medicine Collaborative
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Lowcountry Infectious Diseases PA
    • Loris, South Carolina, United States, 29569
      • Main Street Physicians Care
  • Texas
    • Carrollton, Texas, United States, 75010
      • Digestive Health Associates of Texas, PA
    • Houston, Texas, United States, 77025
      • Kelsey Seybold Clinic
    • Houston, Texas, United States, 77090
      • 1960 Family Practice P.A.
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute LLC
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Infectious Diseases Associates of Central Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Active Comparator: CP101	Biological: 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 CDI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CDI recurrence through week 8 as evidenced by positive toxin EIA or positive toxigenic culture	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment emergent adverse events through week 8 as measure by number of events	Week 8
CDI recurrence through week 24 as evidenced by positive toxin EIA or positive toxigenic culture	Week 24
Treatment emergent adverse events through week 24 as measure by number of events	Week 24

Other Outcome Measures

Outcome Measure	Time Frame
Improvement of intestinal microbiome diversity at week 1 as determined by 16S ribosomal ribonucleic acid (rRNA) gene amplicon sequencing	Week 1

Collaborators and Investigators

• Sponsor: Finch Research and Development LLC.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: FMT; CDI; Fecal transplant; Fecal microbiota transplant; Fecal microbiota transplantation; C. difficile infection; recurrent Clostridium difficile infection; Clostriodioides difficile infection; recurrent C. diff infection; multiple recurrent C. diff infection; c. diff; microbiota transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Recurrence
• Other Study ID Numbers: FIN-CDI-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No