The Clostridioides Difficile Trial of REC-3964

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-05-06

Brief Summary

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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).

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Detailed Description

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

Conditions

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Recurrent Clostridioides Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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REC-3964 High-dose

Participants will receive 500 mg REC-3964 q12h REC-3964 250 mg capsules

Group Type EXPERIMENTAL

REC-3964

Intervention Type DRUG

REC-3964 given at a dose of either 500 mg q12h or 250 mg q12h

REC-3964 Low-dose

Participants will receive 250 mg REC-3964 q12h REC-3964 250 mg capsules

Group Type EXPERIMENTAL

REC-3964

Intervention Type DRUG

REC-3964 given at a dose of either 500 mg q12h or 250 mg q12h

Observation

Participants will undergo watchful waiting

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REC-3964

REC-3964 given at a dose of either 500 mg q12h or 250 mg q12h

Intervention Type DRUG

Eligibility Criteria

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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).

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

115 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No