[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618234":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":34,"locations":41,"responsibleParty":62,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fidaxomicin","ACTIVE_COMPARATOR","Fidaxomicin 200mg PO BID x 10 days",[13],"Drug: Fidaxomicin",{"label":15,"type":16,"description":17,"interventionNames":18},"Vancomycin T-P","EXPERIMENTAL","Vancomycin 125mg PO QID x2 weeks, then 125mg PO BID x2 weeks, then 125mg PO daily x2 weeks",[19],"Drug: Vancomycin capsule",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":26,"description":17,"armGroupLabels":27,"otherNames":24},"Vancomycin capsule",[15],[29,32],{"name":30,"affiliation":5,"role":31},"Emily McDonald, MD MSc","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":5,"role":31},"Todd Lee, MSc MPH",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Connor Prosty, MD","CONTACT","514-934-1934","53333","connor.prosty@mail.mcgill.ca",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"McGill University Health Centre","RECRUITING","Montreal","Quebec","H4A0B1","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-73.58781,45.50884,{"lat":54,"lon":53},[57,59,60],{"name":36,"role":37,"phone":38,"phoneExt":58,"email":40},"x53333",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":61,"role":31,"phone":24,"phoneExt":24,"email":24},"Todd Lee, MD MPH",{"type":31,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Emily McDonald","Associate Professor of Medicine","100618234","phase-3-vancomycin-taper-to-prevent-recurrent-clostridioides-difficile-100618234",false,"NCT07328971","Vancomycin Taper to Prevent Recurrent Clostridioides Difficile","Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial","TAPER-V2","Inclusion Criteria\n\n1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.\n2. First episode or first recurrence of CDI (i.e., second episode within 120 days) defined by a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and\u002For cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in \\\u003C24 hours with a duration \\>24 hours, endoscopic\u002Fhistologic evidence of pseudomembranous colitis, or ileus. For eligibility, CDI will be considered a first recurrence if the patient experiences 2 episodes within a 120-day timeframe; those with a first ever episode, or 2 episodes separated by more than 120 days, will be categorized as a first-episode.\n\nClinical Exclusion Criteria\n\n1. Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy).\n2. Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA).\n3. Inability to take medications orally.\n4. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.\n5. Severe intolerance or allergy to oral vancomycin or fidaxomicin.\n6. The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness.\n7. Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and\u002For toxic megacolon.\n8. Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI.\n9. Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available.\n10. Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available.\n11. Patients who have had ≥3 episodes of CDI in the last 1 year.\n12. Treating team declined participation.\n13. Prior enrolment in TAPER-V2.\n\nAdministrative Exclusion Criteria\n\n1. Prior enrollment in this trial.\n2. Inability to consent without a healthcare proxy.\n3. Lack of health insurance.\n4. Anticipated transfer to a site not involved in this trial, or to a palliative care ward\n5. Patient-declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.","ALL","18 Years",{"count":76,"type":77},500,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides difficile infections (rCDI). The aim of this trial is:\n\n1\\) For first episodes and first recurrences of CDI, to test whether a vancomycin P-T is non-inferior to 10-days of fidaxomicin for the prevention of rCDI at 56 days",[83],"Clostridia Difficile Colitis",[85,86,87,88],"Clostridoides difficile","Recurrent Clostridioides difficile","C. difficile","Clostridium difficile","2026-06-19",{"date":91,"type":92},"2026-06-24","ACTUAL",{"date":94,"type":92},"2026-04-24",{"date":96,"type":77},"2030-11-01",{"name":5,"class":6},1]