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

February 24, 2023 updated by: Finch Research and Development LLC.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
CDI recurrence through week 8 as evidenced by positive toxin EIA or positive toxigenic culture
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Treatment emergent adverse events through week 8 as measure by number of events
Time Frame: Week 8
Week 8
CDI recurrence through week 24 as evidenced by positive toxin EIA or positive toxigenic culture
Time Frame: Week 24
Week 24
Treatment emergent adverse events through week 24 as measure by number of events
Time Frame: Week 24
Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Improvement of intestinal microbiome diversity at week 1 as determined by 16S ribosomal ribonucleic acid (rRNA) gene amplicon sequencing
Time Frame: Week 1
Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Finch Research and Development LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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