Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection (PRISM-EXT)
|ClinicalTrials.gov Identifier: NCT03497806|
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2018
Last Update Posted : September 10, 2019
This is an open-label extension of CDI-001 (subsequently referred to as PRISM 3), and is evaluating the safety and efficacy in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101.
Approximately 70 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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Recurrent Clostridium Difficile C. Diff C. Difficile Recurrent C. Diff Finch Crestovo Recurrent CDI rCDI CDI||Biological: CP101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: High Dose CP101
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.
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.
Other Name: Full-Spectrum Microbiota™
- Proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection [ Time Frame: Week 8 ]Sustained clinical cure rate
- Proportion of participants with adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 8 ]Mapped to System Organ Class
- Proportion of subjects experiencing recurrent CDI with ribosomal NAP1/BI/027 C. difficile subtype at Week 8 [ Time Frame: 8 weeks ]North American Pulse-field type 1 (NAP1)/BI/027 subtyping will be performed if symptoms are consistent with recurrent CDI.
- Proportion of subjects experiencing sustained clinical cure at Week 24 [ Time Frame: 24 Weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497806
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|Study Director:||Zain Kassam, MD, MPH||Finch Research and Development LLC.|