Ibezapolstat for Clostridium Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clostridium Infections+3 More
Ibezapolstat - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat C. difficile infection. The drug is safe and effective, and also affects the microbiome.

Eligible Conditions
  • Clostridium Infections
  • CMC-CDI

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 38 days

10 days
Plasma and fecal concentrations of ACX-362E
12 days
Clinical cure
Time from outset of treatment to the first formed bowel movement
Time to resolution of diarrhea
38 days
Change in EQ-5D-5L Quality of Life scores
Microbiome effects
Percentage of patients with adverse events
Percentage of patients with sustained clinical cure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Vancomycin
1 of 2
Ibezapolstat
1 of 2

Active Control

Experimental Treatment

74 Total Participants · 2 Treatment Groups

Primary Treatment: Ibezapolstat · No Placebo Group · Phase 2

Ibezapolstat
Drug
Experimental Group · 1 Intervention: Ibezapolstat · Intervention Types: Drug
Vancomycin
Drug
ActiveComparator Group · 1 Intervention: Vancomycin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 38 days

Who is running the clinical trial?

Acurx Pharmaceuticals LLCLead Sponsor
Acurx Pharmaceuticals Inc.Lead Sponsor
Michael H Silverman, MDStudy DirectorAcurx Pharmaceuticals Inc.
15 Previous Clinical Trials
2,647 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female 18 to 90 years of age, inclusive, at the time of Screening.
You are able to read, understand, and sign the informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Arizona100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Acurx Site #118100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
References