Recurrent C. Difficile InfectionPhase 3PRISM4NCT05153499
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
A Phase 3 study testing CP101 in people with Recurrent C. Difficile Infection, run by Finch Research and Development LLC. at 68 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent C. Difficile Infection
- What is being tested?
- CP101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 68 sitesin 2 countries
- Study dates
- 15 Nov 2021to 24 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
68 sites in 2 countries.
68 sites in 2 countries
United States61 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
University of Colorado School of Medicine
Aurora, Colorado, 80045
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Metro Infectious Disease Consultants
Burr Ridge, Illinois, 60527
Mercury Street Medical Group
Butte, Montana, 59701
Digestive Health Associates of Texas, PA
Carrollton, Texas, 75010
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Lowcountry Infectious Diseases PA
Charleston, South Carolina, 29414
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Gastro Health LLC
Cincinnati, Ohio, 45219
Iowa Clinic
Des Moines, Iowa, 50266
TruCare Internal Medicine & Infectious Diseases
DuBois, Pennsylvania, 15801
NorthShore University HealthSystem
Evanston, Illinois, 60077
William Beaumont Hospital
Farmington Hills, Michigan, 48336
University of Florida Health
Gainesville, Florida, 32608
Brody School of Medicine at ECU
Greenville, North Carolina, 27834
MedPharmics LLC
Gulfport, Mississippi, 39503
Medical Research Center of Connecticut LLC
Hamden, Connecticut, 06518
Hartford Hospital
Hartford, Connecticut, 06106
Kelsey Seybold Clinic
Houston, Texas, 77025
1960 Family Practice P.A.
Houston, Texas, 77090
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
ENCORE Borland-Groover Clinical Research
Jacksonville, Florida, 32256
Regional GI
Lancaster, Pennsylvania, 17601
Main Street Physicians Care
Loris, South Carolina, 29569
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501
North Shore University Hospital-(Manhasset)
Manhasset, New York, 11030
Loyola University Medical Center
Maywood, Illinois, 60153
San Marcus Research Clinic Inc
Miami, Florida, 33014
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Reliant Medical Research
Miami, Florida, 33165
Facey Medical Foundation
Mission Hills, California, 91345
Gastroenterology Group of Naples
Naples, Florida, 34102
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
NYU Langone Medical Center
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
Christiana Care Health System
Newark, Delaware, 19718
Digiovanna Institute For Medical Education and Research
North Massapequa, New York, 11758
Henry Ford Health System
Novi, Michigan, 48377
Kaiser Permanente Division of Research
Oakland, California, 94611
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
Pinehurst Medical Clinic Inc
Pinehurst, North Carolina, 28374
Women's Medicine Collaborative
Providence, Rhode Island, 02904
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
Southern Star Research Institute LLC
San Antonio, Texas, 78229
UCSF
San Francisco, California, 94143
Guthrie Clinic
Sayre, Pennsylvania, 18840
Theia Clinical Research, LLC
St. Petersburg, Florida, 33709
Stanford Healthcare
Stanford, California, 94305
Central New York Research Corporation
Syracuse, New York, 13210
Guardian Angel Research
Tampa, Florida, 33614
St Joseph's Comprehensive Research Institute
Tampa, Florida, 33614
Montefiore Medical Center
The Bronx, New York, 10467
George Washington University School of Medicine and Health
Washington D.C., District of Columbia, 20052
St. Charles Clinical Research, LLC
Weldon Spring, Missouri, 63304
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Canada7 sites
University of Calgary - Calgary Health Region
Calgary, Alberta, T2N 4N1
Dalhousie University
Halifax, Nova Scotia, B3H 4R2
Saint Joseph's Health Care London
London, Ontario, N6A 4V2
CARe Clinic
Red Deer, Alberta, T4P 1K4
University Health Network
Toronto, Ontario, M5G 1L7
Yazdan Medical Corporation
Vancouver, British Columbia, V7M 1Z8
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8
About this study
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)
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.
- Conditions
- Recurrent C. Difficile Infection
- Being tested
- CP101, Placebo
- 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
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP101Biological
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).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CP101 | Active comparator | Not described Receives: Biological: CP101 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Clinical Cure Through Week 8
No data displayed because Outcome Measure has zero participants analyzed.
Measured: Week 8
Secondary outcomes (2)
Sustained Clinical Cure Through Week 24
No data displayed because Outcome Measure has zero participants analyzed.
Measured: Week 24
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start15 Nov 2021
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Why it stopped: The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent C. Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finch Research and Development LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153499
- Sponsor's protocol ID
- FIN-CDI-301
- Acronym
- PRISM4
- Status last verified
- Oct 2023
- First submitted
- 17 Nov 2021
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05153499
- Acronym / sponsor ID
- PRISM4 / FIN-CDI-301
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Finch Research and Development LLC.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP101 | Active comparator | Biological: CP101 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP101CP101 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). | Biological | CP101 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Sustained Clinical Cure Through Week 8
Time frame: Week 8
No data displayed because Outcome Measure has zero participants analyzed.
2 secondary outcomes
Sustained Clinical Cure Through Week 24
Time frame: Week 24
CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Recurrent C. Difficile Infection
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingPhase 2
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Clostridioides Difficile Infection
Active, not recruitingPhase 2/3
LMN-201 for Prevention of C. Difficile Infection Recurrence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
68 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CP101 in people with Recurrent C. Difficile Infection, run by Finch Research and Development LLC. at 68 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Clinical Cure Through Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.