Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

  • STATUS
    Recruiting
  • End date
    Apr 4, 2021
  • participants needed
    70
  • sponsor
    Finch Research and Development LLC.
Updated on 10 August 2020
Investigator
Shrish Budree, MD
Primary Contact
Washington DC (4.5 mi away) Contact
+47 other location
antibiotic therapy
antibiotics
microbiota
clostridium difficile

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. 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.

Details
Treatment CP101
Clinical Study IdentifierNCT03497806
SponsorFinch Research and Development LLC.
Last Modified on10 August 2020

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