Recruiting
Phase 2

ACX-362E

Sponsor:

Acurx Pharmaceuticals Inc.

Code:

NCT07513285

Conditions

Clostridium Difficile Infection Recurrence

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ibezapolstat

Study Details

Brief summary:

Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).

Conditions

Clostridium Difficile Infection Recurrence

Study ID

NCT07513285

Start date

Aug 6, 2026

Status verified date

Aug, 2026

Completion date

Nov 24, 2027

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibezapolstat

Active investigational antibacterial agent

Interventions

Ibezapolstat

Ibezapolstat 450 mg po Q12H x14 days

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Dee Rodriguez

7742665290dee.rodriguez@acurxpharma.com

Locations

L&A Morales Healthcare, Inc

Recruiting

Hialeah, Florida, United States, 33012

Snake River Research PLLC

Recruiting

Idaho Falls, Idaho, United States, 83404

More Information

Sponsor

Acurx Pharmaceuticals Inc.

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Clostridioides difficile
  • Cdiff
  • Recurrent Clostridioides difficile

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Acurx Pharmaceuticals Inc. on 2026-08-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.