Clostridium Difficile InfectionPhase 2PRISM-EXTNCT03497806
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
A Phase 2 study testing CP101 in people with Clostridium Difficile Infection and Recurrent Clostridium Difficile Infection, run by Finch Research and Development LLC. at 57 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff
- What is being tested?
- CP101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 57 sitesin 2 countries
- Study dates
- 1 May 2018to 1 Apr 2021
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- Pregnant, breast-feeding, or considering becoming pregnant during the study
- Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
- Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
- Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
- Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
- Major intra-abdominal surgery within the past 60 days prior to Screening
Show all 10Show fewer
- 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
- History of total colectomy/ileostomy or bariatric surgery
- Planned hospitalization or invasive surgery during the study
- Severe acute illness unrelated to CDI
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States53 sites
Annandale
Annandale, Virginia, 22003
Atlanta
Atlanta, Georgia, 30322
Aurora
Aurora, Colorado, 80045
Boston
Boston, Massachusetts, 02115
Bridgeport
Bridgeport, Connecticut, 06610
Burr Ridge
Burr Ridge, Illinois, 60527
Butte
Butte, Montana, 59701
Chapel Hill
Chapel Hill, North Carolina, 27599
Charlottesville
Charlottesville, Virginia, 22908
Chicago
Chicago, Illinois, 60637
Cincinnati
Cincinnati, Ohio, 45267
Detroit
Detroit, Michigan, 48202
Evanston
Evanston, Illinois, 60201
Grafton
Grafton, Wisconsin, 53024
Hamden
Hamden, Connecticut, 06518
Idaho Falls
Idaho Falls, Idaho, 83404
Indianapolis
Indianapolis, Indiana, 46202
Jacksonville
Jacksonville, Florida, 32216
Kinston
Kinston, North Carolina, 28501
Los Angeles
Los Angeles, California, 90095
Maywood
Maywood, Illinois, 60153
Morristown
Morristown, New Jersey, 07960
Murrieta
Murrieta, California, 92563
Naples
Naples, Florida, 34102
Nashville
Nashville, Tennessee, 37212
New Orleans
New Orleans, Louisiana, 70121
New York
New York, New York, 10016
New York
New York, New York, 10021
New York
New York, New York, 10029
Oakland
Oakland, California, 94705
Ogden
Ogden, Utah, 84403
Pinehurst
Pinehurst, North Carolina, 28374
Pinellas Park
Pinellas Park, Florida, 33781
Poland
Poland, Ohio, 44514
Portland
Portland, Oregon, 97239
Providence
Providence, Rhode Island, 02904
Rochester
Rochester, Minnesota, 55905
Royal Oak
Royal Oak, Michigan, 48073
St. Paul
Saint Paul, Minnesota, 55102
Salt Lake City
Salt Lake City, Utah, 84124
San Antonio
San Antonio, Texas, 78229
San Diego
San Diego, California, 92123
San Francisco
San Francisco, California, 94115
Scottsdale
Scottsdale, Arizona, 85054
Seattle
Seattle, Washington, 98101
Shawnee
Shawnee Mission, Kansas, 66217
Somers Point
Somers Point, New Jersey, 08244
Tampa
Tampa, Florida, 33614
Bronx
The Bronx, New York, 10467
Washington DC
Washington D.C., District of Columbia, 20422
West Des Moines
West Des Moines, Iowa, 50266
Winston-Salem
Winston-Salem, North Carolina, 27103
Winston-Salem
Winston-Salem, North Carolina, 27157
Canada4 sites
Calgary
Calgary, Alberta, T2N 2T9
Halifax
Halifax, Nova Scotia, B3H4C5
London
London, Ontario, N6A 4V2
Toronto
Toronto, Ontario, M5G 2C4
About this study
Official title: PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
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.
- Conditions
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI, Recurrent C. Diff, rCDI
- Being tested
- CP101
- Keywords
- Clostridium Difficile Infection, CP101, Crestovo, FMT, CDI, C. difficile, C. diff, Recurrent Clostridium Difficile Infection, Recurrent C. diff, Recurrent CDI, Finch, Fecal transplant, Fecal microbiota transplant, rCDI, Finch Therapeutics
- Medical subject headings
- Clostridium Infections, Diabetes Insipidus, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP101Biological
Also called Full-Spectrum Microbiota™
Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
| Study group | Role | What they receive |
|---|---|---|
| High Dose CP101 | Experimental | The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program. Receives: Biological: CP101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 8
Occurence of Treatment Emergent Adverse Events (TEAEs)
Measured: Week 8
Secondary outcomes (1)
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.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 May 2018
- Primary completion31 Dec 2020
- Study completion1 Apr 2021
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 Clostridium 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finch Research and Development LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Zain Kassam, MD, MPH, Study director, Finch Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497806
- Sponsor's protocol ID
- CP101-CDI-E02
- Acronym
- PRISM-EXT
- Status last verified
- Aug 2022
- First submitted
- 6 Apr 2018
- Last updated
- 30 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT03497806
- Acronym / sponsor ID
- PRISM-EXT / CP101-CDI-E02
- Conditions
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI, Recurrent C. Diff, rCDI
- Keywords
- Clostridium Difficile Infection, CP101, Crestovo, FMT, CDI, C. difficile, C. diff, Recurrent Clostridium Difficile Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Finch Research and Development LLC.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Posted 30 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Dose CP101 | Experimental | Biological: CP101The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Pregnant, breast-feeding, or considering becoming pregnant during the study
- Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
- Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
- Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
- Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
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 |
|---|---|---|
| CP101Also: Full-Spectrum Microbiota™Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI. | Biological | High Dose CP101 |
Primary outcome
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Time frame: Up to Week 8
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.
Occurence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 8
1 secondary outcome
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Time frame: Up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile Infection
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
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
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
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.
Zain Kassam, MD, MPH study director
Finch Therapeutics
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP101 in people with Clostridium Difficile Infection and Recurrent Clostridium Difficile Infection, run by Finch Research and Development LLC. at 57 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 0 inclusion and 10 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: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Aug 2022). 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?
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication (time frame: Up to Week 8). The study lists 2 primary outcomes in all. 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 30 Aug 2022.