Clostridium Difficile Infection Clinical Trial
— PRISM-EXTOfficial title:
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Verified date | August 2022 |
Source | Finch Research and Development LLC. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
Status | Completed |
Enrollment | 132 |
Est. completion date | April 1, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 1. Ability to provide written informed consent; 2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI 3. An outpatient prior to Treatment 4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period. Exclusion Criteria: 1. Pregnant, breast-feeding, or considering becoming pregnant during the study 2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) 3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome 4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization 5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study 6. Major intra-abdominal surgery within the past 60 days prior to Screening 7. Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry 8. History of total colectomy/ileostomy or bariatric surgery 9. Planned hospitalization or invasive surgery during the study 10. Severe acute illness unrelated to CDI |
Country | Name | City | State |
---|---|---|---|
Canada | Calgary | Calgary | Alberta |
Canada | Halifax | Halifax | Nova Scotia |
Canada | London | London | Ontario |
Canada | Toronto | Toronto | Ontario |
United States | Annandale | Annandale | Virginia |
United States | Atlanta | Atlanta | Georgia |
United States | Aurora | Aurora | Colorado |
United States | Boston | Boston | Massachusetts |
United States | Bridgeport | Bridgeport | Connecticut |
United States | Bronx | Bronx | New York |
United States | Burr Ridge | Burr Ridge | Illinois |
United States | Butte | Butte | Montana |
United States | Chapel Hill | Chapel Hill | North Carolina |
United States | Charlottesville | Charlottesville | Virginia |
United States | Chicago | Chicago | Illinois |
United States | Cincinnati | Cincinnati | Ohio |
United States | Detroit | Detroit | Michigan |
United States | Evanston | Evanston | Illinois |
United States | Grafton | Grafton | Wisconsin |
United States | Hamden | Hamden | Connecticut |
United States | Idaho Falls | Idaho Falls | Idaho |
United States | Indianapolis | Indianapolis | Indiana |
United States | Jacksonville | Jacksonville | Florida |
United States | Kinston | Kinston | North Carolina |
United States | Los Angeles | Los Angeles | California |
United States | Maywood | Maywood | Illinois |
United States | Morristown | Morristown | New Jersey |
United States | Murrieta | Murrieta | California |
United States | Naples | Naples | Florida |
United States | Nashville | Nashville | Tennessee |
United States | New Orleans | New Orleans | Louisiana |
United States | New York | New York | New York |
United States | New York | New York | New York |
United States | New York | New York | New York |
United States | Oakland | Oakland | California |
United States | Ogden | Ogden | Utah |
United States | Pinehurst | Pinehurst | North Carolina |
United States | Pinellas Park | Pinellas Park | Florida |
United States | Poland | Poland | Ohio |
United States | Portland | Portland | Oregon |
United States | Providence | Providence | Rhode Island |
United States | Rochester | Rochester | Minnesota |
United States | Royal Oak | Royal Oak | Michigan |
United States | St. Paul | Saint Paul | Minnesota |
United States | Salt Lake City | Salt Lake City | Utah |
United States | San Antonio | San Antonio | Texas |
United States | San Diego | San Diego | California |
United States | San Francisco | San Francisco | California |
United States | Scottsdale | Scottsdale | Arizona |
United States | Seattle | Seattle | Washington |
United States | Shawnee | Shawnee Mission | Kansas |
United States | Somers Point | Somers Point | New Jersey |
United States | Tampa | Tampa | Florida |
United States | Washington DC | Washington | District of Columbia |
United States | West Des Moines | West Des Moines | Iowa |
United States | Winston-Salem | Winston-Salem | North Carolina |
United States | Winston-Salem | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Finch Research and Development LLC. | Medpace, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication | Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period. | Up to Week 8 | |
Primary | Occurence of Treatment Emergent Adverse Events (TEAEs) | Week 8 | ||
Secondary | Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication | Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period. | Up to Week 24 |
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