ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
Completed · Phase 2 · Has a placebo group
Conditions studied: Clostridium Difficile Infection
In brief
Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E \[ibezapolstat\] in patients with C. difficile infection (CDI).
Key facts
- Study ID
- NCT04247542
- Run by
- Acurx Pharmaceuticals Inc.
- People needed
- 53
- Starts
- 2020-03-06
- Expected to finish
- 2023-11-15
- Last updated by the study team
- 2025-01-17
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female 18 to 90 years of age, inclusive, at the time of Screening.
- Capable of reading, understanding, and signing the written informed consent; able to adhere to all study procedures and attend all scheduled study visits.
- Confirmed diagnosis of mild or moderate CDI as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines (McDonald et al. 2018). Subjects will be diagnosed with CDI based on clinical and laboratory findings:
- The presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before dosing; an unformed stool is defined as a Type 5, 6, or 7 on the Bristol Stool Chart (Appendix 2)
- A stool test result positive for the presence of C. difficile free toxins using tests that detect toxin A/B (and it is prospectively agreed with the Sponsor). The Sponsor will provide a toxin A/B test kit if the site does not have it as part of standard of care test.
- Mild or moderate CDI as defined as a white blood cell count of ≤ 15000 cells/mL and a serum creatinine level < 1.5 mg/dL.
You may not qualify if…
- Received more than 24 hours of dosing (> 4 doses) of oral vancomycin for the current episode of CDI before first dose of study drug.
- Received more than 24 hours of dosing (> 2 doses) of oral fidaxomicin for the current episode of CDI before first dose of study drug.
- Received more than 24 hours of dosing (> 3 doses) of oral/IV metronidazole for the current episode of CDI before first dose of study drug.
- Received any other antibacterial therapy for the current CDI episode within 48 hours before the first dose of study drug.
- Subjects considered treatment failures on prior antibiotics for their current episode of CDI will be excluded.
- More than 3 episodes of CDI in the previous 12 months or more than 1 prior episode in the last 3 months, excluding the current episode.
- Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure less than 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon.
- Elevated liver transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) greater than 2 times ULN.
- Active inflammatory bowel disease (Crohn's disease, ulcerative colitis, Irritable Bowel Syndrome with chronic diarrhea).
- Any other non-C. difficile diarrhea.
- Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, a parasite, or virus within the past 2 weeks.
- Had a known positive diagnostic test for other relevant gastrointestinal [GI] pathogens in the 2 weeks before study drug treatment and/or colonization/infection by ova or parasites.
- Major GI surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
- Prior or current use of anti-C. difficile toxin antibodies.
- Have received a vaccine against C. difficile or its toxins.
- Anticipated that systemic antibacterial therapy for a non-CDI infection will be required for > 7 days after start of study therapy.
- Actively taking anti-diarrheals, and unable to discontinue anti-diarrheal medication, or any medication with the potential to slow bowel movement (for opiates, a stable dose, including use as needed, is permitted).
- Actively taking Saccharomyces boulardii and unwilling to discontinue during the study period.
- Received a fecal transplant in the previous 3 months.
- Received laxatives in the last 48 hours.
- Unable or unwilling to stop taking oral probiotics for the duration of the study.
- Received intravenous immunoglobulin within 3 months before study drug treatment.
- Sepsis.
- Have a known current history of significantly compromised immune system such as:
- Subjects with a known history of human immunodeficiency virus infection and CD4 <200 cells/mm3 within 6 months of start of study therapy.
Where it is running
- Acurx Site #118: Dr Janet Reiser — Scottsdale, Arizona, United States
- Acurx Site #115: Dr Neera Grover — Apple Valley, California, United States
- Acurx Site #125: Dr Karen Simon — Camarillo, California, United States
- Acurx Site #111: Dr Jatinder Pruthi — Lancaster, California, United States
- Acurx Site #131: Dr Michael Jardula — Palm Springs, California, United States
- Acurx Site #129: Dr Stuart Cohen — Sacramento, California, United States
- Acurx Site #105 — Doral, Florida, United States
- Acurx Site #122: Dr Faride Ramos — Doral, Florida, United States
- Acurx Site #101: Dr Idalia Acosta — Miami, Florida, United States
- Acurx Site #124: Dr Yunior Silva-Barrero — Miami, Florida, United States
- Acurx Site #108: Dr Idania Garcia Del Sol — Miami, Florida, United States
- Acurx Site #116: Dr Erick Juarez — Miami, Florida, United States
- Acurx Site #119: Dr Jorge Paoli-Bruno — Miami, Florida, United States
- Acurx Site #107: Dr Belkis Delgado — Miami Springs, Florida, United States
- Acurx Site #117: Dr Rafael Companioni — Panama City, Florida, United States
- Acurx Site #102: Dr Richard Nathan — Idaho Falls, Idaho, United States
- Acurx Site #123: Dr Harry Schrager — Newton, Massachusetts, United States
- Acurx Site #104: Dr JeanMarie Houghton — Worcester, Massachusetts, United States
- Acurx Site #103: Dr John Pullman — Butte, Montana, United States
- Acurx Site #130: Dr Michael DiGiovanna — North Massapequa, New York, United States
- Acurx Site #127: Dr Christopher Connolley — Winston-Salem, North Carolina, United States
- Acurx Site #126: Dr Andrew Pearson — Myrtle Beach, South Carolina, United States
- Acurx Site #114: Dr Eugene Ryan — Chattanooga, Tennessee, United States
- Acurx Site #121: Dr Ramesh Gowrappala — Houston, Texas, United States
- Acurx Site #120: Dr Vanna Gold — Lampasas, Texas, United States
Full record on ClinicalTrials.gov
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