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ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection

NCT04247542 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-01-17

Study results available
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Summary

Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E \[ibezapolstat\] in patients with C. difficile infection (CDI).

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Ibezapolstat

Investigational antibacterial agent

DRUG

Vancomycin

Active comparator

Sponsors & Collaborators

  • Acurx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Michael H Silverman, MD · Acurx Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2023-10-03
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247542 on ClinicalTrials.gov