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

Recurrent C. Difficile Infection Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05153499
• Other study ID #: FIN-CDI-301
• Status: Terminated
• Phase: Phase 3
• Start date: November 15, 2021
• Est. completion date: February 24, 2023

Study information

• Verified date: October 2023
• Source: Finch Research and Development LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrence
• Recurrent C. Difficile Infection

Intervention

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 Clostridioides difficile infection (CDI).

Other:
• Placebo
Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Finch Research and Development LLC.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement of Intestinal Microbiome Diversity at Week 1 as Determined by 16S Ribosomal Ribonucleic Acid (rRNA) Gene Amplicon Sequencing	No data displayed because Outcome Measure has zero participants analyzed.	Week 1
Primary	Sustained Clinical Cure Through Week 8	No data displayed because Outcome Measure has zero participants analyzed.	Week 8
Secondary	Sustained Clinical Cure Through Week 24	No data displayed because Outcome Measure has zero participants analyzed.	Week 24
Secondary	CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture	No data displayed because Outcome Measure has zero participants analyzed.	Week 24