ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (NCT04247542) | Clinical Trial Compass
CompletedPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
United States53 participantsStarted 2020-03-06
Plain-language summary
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).
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Segment 2A: Clinical Cure (CC) of Clostridioides Difficile Infection (CDI) Per Protocol (PP)/Modified Intent-to-Treat (mITT) Population
Timeframe: 12 days
2
Segment 2B Per Protocol (PP) Population: Clinical Cure (CC) of Clostridioides Difficile Infection (CDI)
. 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.