Clinical Trials Logo
  1. Home
  2. Clostridium Difficile Infection
  3. NCT04247542

ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection

Clostridium Difficile Infection Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

This Phase 2, multicenter, open-label single-arm segment (2A) followed by a double-blind, randomized, active-controlled segment (2B) is designed to evaluate ACX-362E in the treatment of CDI. Segment 2A of this trial was an open-label study of up to 20 patients at 6 study centers and was terminated early at 10 patients based on the protocol-specified Trial Oversight Committee's assessment of the compelling efficacy and safety data. Patients were treated with 450 mg of oral ibezapolstat bid for 10 days. In segment 2A all (10 of 10) patients were cured of CDI at end of treatment and all (10 of 10) were sustained clinical cures 30 days after EOT. Ibezapolstat was well tolerated with no reported SAEs. The trial will advance to Segment 2B which is a double-blind comparison of ibezapolstat to the standard of care, oral vancomycin, in approximately 64 subjects (1-1 randomization) at up to approximately 15 sites. Subjects will be evaluated for cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles. Pharmacokinetic (PK) testing for systemic exposure will be performed on blood samples. Stool samples will be tested for study drug concentration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04247542
Study type Interventional
Source Acurx Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date March 6, 2020
Completion date November 15, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02214771 - Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients N/A
Withdrawn NCT01552668 - Fidaxomicin to Prevent Clostridium Difficile Colonization Phase 4
Recruiting NCT03325855 - Fecal Microbiota Transplant National Registry
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Suspended NCT03350711 - A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
Withdrawn NCT03643887 - Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients Phase 2
Terminated NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
Completed NCT03710694 - Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI) N/A
Completed NCT02865616 - MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI) Phase 1
Recruiting NCT04940468 - High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology N/A
Completed NCT02589847 - Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT02086916 - Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection N/A
Completed NCT01230957 - Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults Phase 2
Completed NCT01241552 - A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) Phase 3
Not yet recruiting NCT04567134 - Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Completed NCT04075422 - Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Recruiting NCT03712722 - Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Recruiting NCT05192148 - Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile N/A