Status:
TERMINATED
The Clostridioides Difficile Trial of REC-3964
Lead Sponsor:
Recursion Pharmaceuticals Inc.
Conditions:
Recurrent Clostridioides Difficile Infection
Eligibility:
All Genders
18-115 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Study was terminated due to sponsor decision. This decision was not related to safety concerns.
Eligibility Criteria
Inclusion
- Key
- 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).
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06536465
Start Date
October 14 2024
End Date
May 6 2025
Last Update
November 17 2025
Active Locations (2)
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1
GANJ - Toms River - Ocean Family Gastroenterology
Toms River, New Jersey, United States, 08755
2
Southern Star Research Institute, LLC
San Antonio, Texas, United States, 78229