Summary

Eligibility
for people ages 18-115 (full criteria)
Location
at San Antonio, Texas and other locations
Dates
study started
study ends

Description

Summary

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile infection (CDI).

Official Title

A Phase 2 Clinical Study of REC-3964 in Adults for the Reduction of Recurrent Clostridioides Difficile Infection (CDI)

Details

Study was terminated due to sponsor decision. This decision was not related to safety concerns.

Keywords

Recurrent Clostridioides Difficile Infection, Cdiff Infection, Clostridiodes difficile infection, Cdiff, Clostridium Infections, REC-3964

Eligibility

You can join if…

Open to people ages 18-115

  • Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin[s] prior to the preceding curative treatment.
  • The CDI episode, severe or otherwise, must have resolved after receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing the preceding curative treatment.
  • Have high risk for rCDI (a recurrent CDI episode within the last 6 months, age ≥65 years, immunocompromised state, or severe CDI with resolution prior to enrollment into the study).

You CAN'T join if...

  • Have an active, symptomatic, chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease.
  • Diarrhea that requires on-study treatment with agents that would confound the interpretation of the study results.

Locations

  • Southern Star Research Institute, LLC
    San Antonio Texas 78229 United States
  • GANJ - Toms River - Ocean Family Gastroenterology
    Toms River New Jersey 08755 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Recursion Pharmaceuticals Inc.
Links
Sign up for this study
ID
NCT06536465
Phase
Phase 2 C. Diff Research Study
Study Type
Interventional
Participants
About 3 people participating
Last Updated