Ibezapolstat for recurrent C. difficile infection in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, multicenter, open-label study evaluates the safety and potential to reduce recurrence of recurrent CDI with ibezapolstat 450 mg taken every 12 hours for 14 days. Up to 20 adults with a recent history of multiple CDI episodes will be treated and followed to assess Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), and CDI recurrence up to Week 24. The trial focuses on adults who meet specific diagnostic criteria and prior antibiotic exposure, excluding those with severe, complicated CDI or recent use of certain therapies. Lead sponsor is Acurx Pharmaceuticals, with participating centers in California, Connecticut, and Florida.

Why it matters

Who can join: the full rules

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 it's running

• Gastroenterolgy Center of Conneticut
  Hamden, Connecticut, United States Recruiting
• Florida International Medical Research
  Coral Gables, Florida, United States Recruiting
• L&A Morales Healthcare, Inc
  Hialeah, Florida, United States Recruiting
• San Marcus Research Clinc, Inc
  Miami Lakes, Florida, United States Recruiting
• Belis Delgado, MD PA
  Miami Springs, Florida, United States Recruiting
• Infectious Disease Consultants of Georgia
  Athens, Georgia, United States Recruiting

Study contacts

• Study coordinator: Dee Rodriguez
• Email: dee.rodriguez@acurxpharma.com
• Phone: 7742665290

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fecal microbiota transplantation for treating recurrent C. difficile infections

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.