Clinical trial NCT06536465: The Clostridioides Difficile Trial of REC-3964
Official title: A Phase 2 Clinical Study of REC-3964 in Adults for the Reduction of Recurrent Clostridioides Difficile Infection (CDI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Clostridioides Difficile Infection
Keywords: Cdiff Infection
Clostridiodes difficile infection
Cdiff
Lead sponsor: Recursion Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The study was terminated due to business decision and there were no safety concerns.

Eligibility criteria: Key Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with Survival Without Recurrence or Requirement for Additional CDI Treatment
timeFrame: 8 weeks
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 8 weeks
measure: Number of Participants with Related TEAEs
timeFrame: Up to 8 weeks
measure: Number of Participants with Serious TEAEs
timeFrame: Up to 8 weeks
measure: Number of Participants with TEAEs Leading to Study Drug Discontinuation
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Rate of Recurrent Clostridioides Difficile Infection (rCDI)
timeFrame: 8 weeks
measure: Time to Recurrence
timeFrame: Up to 8 weeks
measure: Number of Participants with Severe rCDI
timeFrame: Up to 8 weeks
measure: Number of Participants with rCDI Associated Hospital Admissions
timeFrame: Up to 8 weeks
measure: Number of Unformed [Types 5-7 on the Bristol Stool Scale] Bowel Movements Per Day
timeFrame: Up to 8 weeks
measure: Maximum Observed Plasma Concentration (Cmax) of REC-3964
timeFrame: Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on Day 1 and Day 15
measure: Time to Maximum Plasma Concentration (Tmax) of REC-3964
timeFrame: Pre-dose, 1 hour, 3 hours, and 6 hours post morning dose on the Day 1 and Day 15
measure: Trough Plasma Concentration (Ctrough) of REC-3964
timeFrame: Pre-dose on Day 15
Other outcomes:
Locations:
city: Toms River
country: United States
facility: GANJ - Toms River - Ocean Family Gastroenterology
state: New Jersey
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC
state: Texas
Study officials:
References: