Clinical trial NCT05153499: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Recurrent C. Difficile Infection
Keywords: C. difficile infection
recurrent Clostridium difficile infection
Clostriodioides difficile infection
recurrent C. diff infection
multiple recurrent C. diff infection
CDI
c. diff
microbiota transplantation
FMT
Fecal microbiota transplantation
Fecal microbiota transplant
Fecal transplant
Lead sponsor: Finch Research and Development LLC.
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
  * 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

Primary outcomes:
measure: Sustained Clinical Cure Through Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Sustained Clinical Cure Through Week 24
timeFrame: Week 24
measure: CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture
timeFrame: Week 24
Other outcomes:
measure: Improvement of Intestinal Microbiome Diversity at Week 1 as Determined by 16S Ribosomal Ribonucleic Acid (rRNA) Gene Amplicon Sequencing
timeFrame: Week 1
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut LLC
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Washington
country: United States
facility: George Washington University School of Medicine and Health
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland-Groover Clinical Research
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Saint Petersburg
country: United States
facility: Theia Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research
state: Florida
city: Tampa
country: United States
facility: St Joseph's Comprehensive Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Burr Ridge
country: United States
facility: Metro Infectious Disease Consultants
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Farmington Hills
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Gulfport
country: United States
facility: MedPharmics LLC
state: Mississippi
city: Weldon Spring
country: United States
facility: St. Charles Clinical Research, LLC
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital-(Manhasset)
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: North Massapequa
country: United States
facility: Digiovanna Institute For Medical Education and Research
state: New York
city: Syracuse
country: United States
facility: Central New York Research Corporation
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: Brody School of Medicine at ECU
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Gastro Health LLC
state: Ohio
city: DuBois
country: United States
facility: TruCare Internal Medicine & Infectious Diseases
state: Pennsylvania
city: Lancaster
country: United States
facility: Regional GI
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic
state: Pennsylvania
city: Providence
country: United States
facility: Women's Medicine Collaborative
state: Rhode Island
city: Charleston
country: United States
facility: Lowcountry Infectious Diseases PA
state: South Carolina
city: Loris
country: United States
facility: Main Street Physicians Care
state: South Carolina
city: Carrollton
country: United States
facility: Digestive Health Associates of Texas, PA
state: Texas
city: Houston
country: United States
facility: Kelsey Seybold Clinic
state: Texas
city: Houston
country: United States
facility: 1960 Family Practice P.A.
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Lynchburg
country: United States
facility: Infectious Diseases Associates of Central Virginia
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary - Calgary Health Region
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Vancouver
country: Canada
facility: Yazdan Medical Corporation
state: British Columbia
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: Saint Joseph's Health Care London
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: