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DNA synthesis inhibitor

Ibezapolstat for Clostridioides Difficile Infection

Phase 2
Waitlist Available
Research Sponsored by Acurx Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 days
Awards & highlights

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.

Who is the study for?
Adults aged 18-90 with mild or moderate Clostridioides difficile infection (CDI), experiencing diarrhea as defined by the Bristol Stool Chart. Participants must have a confirmed diagnosis of CDI, not be on certain treatments like immunoglobulins, fecal transplants, or specific antibiotics for CDI before the study. They should not have inflammatory bowel disease, other non-C. difficile diarrhea causes, severely compromised immune systems, recent major GI surgery, or require long-term non-CDI antibiotics.Check my eligibility
What is being tested?
The trial is testing ACX-362E [ibezapolstat] against vancomycin to see which is safer and more effective for treating CDI. It will also look at how ibezapolstat affects the body (pharmacokinetics), its concentration in feces and its impact on gut bacteria (fecal microbiome).See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical antibiotic-related issues such as stomach upset, allergic reactions, changes in liver enzymes indicative of liver stress or damage and alterations to normal gut flora leading to symptoms like bloating or discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 38 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical cure
Percentage of patients with adverse events
Secondary outcome measures
Percentage of patients with sustained clinical cure
Plasma and fecal concentrations of ACX-362E
Other outcome measures
Change in EQ-5D-5L Quality of Life scores
Microbiome effects
Time from outset of treatment to the first formed bowel movement
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IbezapolstatExperimental Treatment1 Intervention
Active investigational antibacterial agent: ibezapolstat 450 mg po Q12H x 10 days
Group II: VancomycinActive Control1 Intervention
Standard of care: Vancomycin 125 mg po Q6H x 10 days

Find a Location

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

Media Library

Ibezapolstat (DNA synthesis inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04247542 — Phase 2
Clostridium Difficile Infection Research Study Groups: Ibezapolstat, Vancomycin
Clostridium Difficile Infection Clinical Trial 2023: Ibezapolstat Highlights & Side Effects. Trial Name: NCT04247542 — Phase 2
Ibezapolstat (DNA synthesis inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04247542 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial have any age restrictions?

"This clinical trial is seeking participants aged 18 to 90. Conversely, there exist separate 209 studies intended for those younger than 18 and 663 specifically designed for seniors 65 years of age or older."

Answered by AI

What risks have been noted with the use of Ibezapolstat?

"Ibezapolstat has been given a safety rating of 2, as it is in Phase 2 clinical trials - meaning there are some data points that support its safety but none yet to confirm efficacy."

Answered by AI

Are any Canadian health centers currently administering this trial?

"Currently, 45 clinical trial sites across the US are enrolling patients. Notable locations include Lynchburg, Camarillo and Miami; however there are numerous other centres participating in this research endeavour to which you should consider travelling if accepted into the study."

Answered by AI

Could I potentially qualify for this medical research project?

"This clinical investigation is searching for 74 volunteers, whose ages span from 18 to 90 years old and who are currently suffering from clostridium infections. To qualify, potential candidates must be of any gender between the designated age range, experience diarrhea (defined as 3 unformed stools within 24 hours before dosing) and meet the other requirements outlined in Appendix 2."

Answered by AI

To what ailment is Ibezapolstat typically recommended as a remedy?

"Ibezapolstat is an effective remedy for staphylococcal infections, staph-induced enterocolitis and other illnesses caused by the Staphylococcus aureus strain."

Answered by AI

How many individuals are actively participating in this clinical research?

"In order for the clinical trial to be considered successful, 74 participants that meet the specified criteria must register. Potential enrollees can visit either Acurx Site #109 in Lynchburg, Virginia or Acurx Site #125 with Dr Karen Simon in Camarillo, California."

Answered by AI

Are there any other reports that have investigated Ibezapolstat?

"Ibezapolstat was first tested at the Sacramento Pediatric Gastroenterology center in 2010. Currently, there are 153 finished clinical trials and 55 active ones taking place mainly around Lynchburg, Virginia."

Answered by AI

Is this research still open for enrollment?

"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical study is actively recruiting participants, with 74 individuals sought out from 45 distinct sites since its commencement in March 2020 and last update of November 2022."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
Acurx Site #118
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
~6 spots leftby Mar 2025