ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
brief summary
Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).
detailed description
Phase 2 multicenter, open-label, single-arm study is designed to evaluate the efficacy, safety, and tolerability of ibezapolstat in the treatment and reduction of recurrence of CDI in an adult patient population that has experienced ≥3 episodes of CDI within the past 12 months. Up to 20 participants will be treated with ibezapolstat 450 mg taken with food every 12 hours for 14 days (28 total doses) and followed for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), rate of CDI recurrence (Up to Week 24), and Extended Clinical Cure (ECC) (Up to Week 24).
official title
A Phase 2 Interventional, Open-Label, Single-Arm Trial of Oral Ibezapolstat (ACX-362E) for Treatment and Reduction of Recurrent Clostridioides Difficile Infection in Patients With Multiple Recurrent Infections (IBZ-PATHFINDER)