NCT07513285 · Acurx Pharmaceuticals Inc.
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
What this study is about
Single-treatment group$1 trial to evaluate the safety and effectiveness of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).
View original scientific description
Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).
Interventions
DRUG
Ibezapolstat
Ibezapolstat 450 mg po Q12H x14 days
Primary outcome measures
Evaluate the rate of CDI Clinical Cure (CC)
Time frame: Day 16
Evaluate the rate of Sustained Clinical Cure (SCC)
Time frame: Day 42
Evaluate the rate of CDI recurrence (rCDI)
Time frame: Day 70
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Sacramento, California
- Hamden, Connecticut
- Coral Gables, Florida
- Hialeah, Florida
- Miami Lakes, Florida
- Miami Springs, Florida
- Athens, Georgia
- Idaho Falls, Idaho
- Skokie, Illinois
- Newton, Massachusetts
- Worcester, Massachusetts
- Detroit, Michigan
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations