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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
206
Orally administered donor derived microbiota
Placebo for CP101
Scottsdale
Scottsdale, Arizona, United States
Los Angeles
Los Angeles, California, United States
Murrieta
Murrieta, California, United States
Oakland
Oakland, California, United States
San Diego
San Diego, California, United States
San Francisco
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Defined in the protocol as sustained clinical cure
Time frame: Week 8
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)
Time frame: Week 8
Time to First Recurrent CDI Episode During the Study
The number of days between IP administration and the first C. Difficile recurrence
Time frame: Week 8
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Defined in the protocol as sustained clinical cure
Time frame: Week 24
Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype
NAP1 is the North American Pulse-field C. difficile subtype.
Time frame: Up to Week 8
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San Francisco, California, United States
Aurora
Aurora, Colorado, United States
Bridgeport
Bridgeport, Connecticut, United States
Hamden
Hamden, Connecticut, United States
Washington DC
Washington D.C., District of Columbia, United States
...and 48 more locations