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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
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. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Time frame: Up to Week 8
Occurence of Treatment Emergent Adverse Events (TEAEs)
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. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Time frame: Up to Week 24
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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 47 more locations