A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
Public ClinicalTrials.gov record NCT05153499. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05153499
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2021 (Actual)
- Primary completion
- Feb 24, 2023 (Actual)
- Completion
- Feb 24, 2023 (Actual)
- Last update posted
- Nov 13, 2023
2021 – 2023
United States locations
- U.S. sites
- 61
- U.S. states
- 28
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| Kaiser Permanente Division of Research | Oakland | California | 94611 | — |
| UCSF | San Francisco | California | 94143 | — |
| Stanford Healthcare | Stanford | California | 94305 | — |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | — |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | — |
| Medical Research Center of Connecticut LLC | Hamden | Connecticut | 06518 | — |
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
| Christiana Care Health System | Newark | Delaware | 19718 | — |
| George Washington University School of Medicine and Health | Washington D.C. | District of Columbia | 20052 | — |
| University of Florida Health | Gainesville | Florida | 32608 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| ENCORE Borland-Groover Clinical Research | Jacksonville | Florida | 32256 | — |
| San Marcus Research Clinic Inc | Miami | Florida | 33014 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Reliant Medical Research | Miami | Florida | 33165 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Theia Clinical Research, LLC | St. Petersburg | Florida | 33709 | — |
| Guardian Angel Research | Tampa | Florida | 33614 | — |
| St Joseph's Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | — |
| Metro Infectious Disease Consultants | Burr Ridge | Illinois | 60527 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60077 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Iowa Clinic | Des Moines | Iowa | 50266 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| William Beaumont Hospital | Farmington Hills | Michigan | 48336 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| MedPharmics LLC | Gulfport | Mississippi | 39503 | — |
| St. Charles Clinical Research, LLC | Weldon Spring | Missouri | 63304 | — |
| Mercury Street Medical Group | Butte | Montana | 59701 | — |
| North Shore University Hospital-(Manhasset) | Manhasset | New York | 11030 | — |
| 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 | — |
| Digiovanna Institute For Medical Education and Research | North Massapequa | New York | 11758 | — |
| Central New York Research Corporation | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Brody School of Medicine at ECU | Greenville | North Carolina | 27834 | — |
| Pinehurst Medical Clinic Inc | Pinehurst | North Carolina | 28374 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Gastro Health LLC | Cincinnati | Ohio | 45219 | — |
| TruCare Internal Medicine & Infectious Diseases | DuBois | Pennsylvania | 15801 | — |
| Regional GI | Lancaster | Pennsylvania | 17601 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Guthrie Clinic | Sayre | Pennsylvania | 18840 | — |
| Women's Medicine Collaborative | Providence | Rhode Island | 02904 | — |
| Lowcountry Infectious Diseases PA | Charleston | South Carolina | 29414 | — |
| Main Street Physicians Care | Loris | South Carolina | 29569 | — |
| Digestive Health Associates of Texas, PA | Carrollton | Texas | 75010 | — |
| Kelsey Seybold Clinic | Houston | Texas | 77025 | — |
| 1960 Family Practice P.A. | Houston | Texas | 77090 | — |
| Southern Star Research Institute LLC | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Infectious Diseases Associates of Central Virginia | Lynchburg | Virginia | 24501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05153499, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 13, 2023 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05153499 live on ClinicalTrials.gov.