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New pill aims to break the cycle of repeat c. diff infections

NCT ID NCT07513285

Disease control Sponsor: Acurx Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This phase 2 trial tests an oral drug called ibezapolstat in 20 people who have had three or more C. diff infections in the past year. The goal is to see if the drug can cure the current infection and reduce the chance of it coming back. Participants will take the drug twice a day for 14 days, and researchers will track cure rates and changes in gut bacteria.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ibezapolstat (ACX-362E)
What this could lead to
If successful, this could provide a new treatment option for people with stubborn, repeat C. diff infections, potentially lowering the chance of future episodes.
What could go wrong
This is a small, early-phase trial with only 20 participants and no comparison group, so results may not apply broadly. The drug may not work as hoped or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins * Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test. * At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin Exclusion Criteria: * Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure \< 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon * Received more than 24 hours of dosing with antibiotics for the current CDI episode: * Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks * Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin \[IVIG\], bezlotoxumab * Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms \> 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year. * Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks. * Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks * Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy). * Known current history of a severely compromised immune system

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridium difficile infection recurrence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Belis Delgado, MD PA

    NOT_YET_RECRUITING

    Miami Springs, Florida, 33166, United States

  • DiGiovanna Institute for Medical Education and Research

    NOT_YET_RECRUITING

    Massapequa, New York, 11758, United States

  • Endevour Health

    NOT_YET_RECRUITING

    Skokie, Illinois, 60077, United States

  • Florida International Medical Research

    NOT_YET_RECRUITING

    Coral Gables, Florida, 33134, United States

  • Gastroenterolgy Center of Conneticut

    NOT_YET_RECRUITING

    Hamden, Connecticut, 06518, United States

  • Henry Ford Hospital

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Infectious Disease Consultants of Georgia

    NOT_YET_RECRUITING

    Athens, Georgia, 30606, United States

  • L&A Morales Healthcare, Inc

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Newton-Wellesley Hospital

    NOT_YET_RECRUITING

    Newton, Massachusetts, 02462, United States

  • Romano, Pontzer & Associated

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15215, United States

  • San Marcus Research Clinc, Inc

    NOT_YET_RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Snake River Research PLLC

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • UC Davis Medical Center

    NOT_YET_RECRUITING

    Sacramento, California, 95817, United States

  • University of Massachusetts Memorial Healthcare

    NOT_YET_RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84115, United States

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