At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
Ibezapolstat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection: A Phase 2A Open-Label Segment Followed by a Phase 2B Double-Blind Vancomycin-Controlled Segment
In Brief
A Phase 2 clinical trial evaluating Ibezapolstat and Vancomycin for Clostridium Difficile Infection. Completed, enrolled 53 participants across 29 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartMar 2020
Primary CompletionOct 2023
Study CompletionNov 2023
TodayJul 2026
First PostedJan 30, 2020
Enrollment StartMar 6, 2020
Primary CompletionOct 3, 2023
Study CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.4 years ago
Interventions
Ibezapolstatdrug
Investigational antibacterial agent
Vancomycindrug
Active comparator