Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

Clostridium Difficile Infection Recurrence Clinical Trial

— PRISM3  

Official title:

A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110133
• Other study ID #: CDI-001
• Status: Completed
• Phase: Phase 2
• Start date: May 8, 2017
• Est. completion date: June 18, 2020

Study information

• Verified date: September 2022
• Source: Finch Research and Development LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile. Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.

Description:

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection (CDI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 18, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent
• Men or women 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

Exclusion Criteria:

• 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
• History of total colectomy/ileostomy or bariatric surgery
• 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
• Planned hospitalization or invasive surgery during the study
• Severe acute illness unrelated to CDI

Related Conditions & MeSH terms

• Clostridium Difficile Infection Recurrence
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence

Intervention

Drug:
• Full Spectrum Microbiota
Orally administered donor derived microbiota
• Placebo
Placebo for CP101

Locations

Country	Name	City	State
Canada	Calgary	Calgary	Alberta
Canada	Halifax	Halifax	Nova Scotia
Canada	Toronto	Toronto	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	Lancaster	Lancaster	Pennsylvania
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

Sponsors (1)

Lead Sponsor	Collaborator
Finch Research and Development LLC.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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	Week 8
Primary	Number of Participants With Occurrence of Treatment Emergent Adverse Events	Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)	Week 8
Secondary	Time to First Recurrent CDI Episode During the Study	The number of days between IP administration and the first C. Difficile recurrence	Week 8
Secondary	Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication	Defined in the protocol as sustained clinical cure	Week 24
Secondary	Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype	NAP1 is the North American Pulse-field C. difficile subtype.	Up to Week 8

External Links

•   trial website