[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632407":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":21,"locations":21,"responsibleParty":22,"collaborators":21,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":21,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":21,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":43,"overallStatus":47,"whyStopped":21,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":21},{"fullName":5,"class":6},"Acurx Pharmaceuticals Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ibezapolstat","EXPERIMENTAL","Active investigational antibacterial agent",[13],"Drug: Ibezapolstat",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Ibezapolstat 450 mg po Q12H x14 days",[9],[20],"ACX-362E",null,{"type":23,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100632407","phase-2-acx-362e-ibezapolstat-for-oral-treatment-of-recurrent-clostridioides-difficile-infection-100632407",false,"NCT07513285","ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection","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)","Inclusion Criteria:\n\n* Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins\n* Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test.\n* At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin\n\nExclusion Criteria:\n\n* Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure \\\u003C 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon\n* Received more than 24 hours of dosing with antibiotics for the current CDI episode:\n* Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks\n* Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin \\[IVIG\\], bezlotoxumab\n* Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms \\> 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year.\n* Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks.\n* Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks\n* Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).\n* Known current history of a severely compromised immune system","ALL","18 Years","90 Years",{"count":35,"type":36},20,"ESTIMATED","INTERVENTIONAL",[39],"PHASE2","Single-arm trial to evaluate the safety and efficacy of ACX-362E \\[ibezapolstat\\] in patients with recurrent C. difficile infection (CDI).",[42],"Clostridium Difficile Infection Recurrence",[44,45,46],"Clostridioides difficile","Cdiff","Recurrent Clostridioides difficile","NOT_YET_RECRUITING","2026-04-02",{"date":50,"type":51},"2026-04-07","ACTUAL",{"date":53,"type":36},"2026-08-19",{"date":55,"type":36},"2027-11-24",{"name":5,"class":6}]