[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629984":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":83,"collaborators":86,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":26,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"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},"Clinically-Supported Antibiotic Treatment Recommendation","ACTIVE_COMPARATOR","Participants in the control group will have antibiotic treatment recommendations based on clinical assessment alone. The BV-signature test result will remain hidden.",[13],"Diagnostic Test: Clinical assessment for antibiotic treatment decision",{"label":15,"type":16,"description":17,"interventionNames":18},"Combined clinical and BV-supported antibiotic treatment recommendation","EXPERIMENTAL","The result of the BV test will be unmasked for the investigators and combined with the clinical assessment of the antibiotic prescription, using a decision matrix. The recommendation will be shared with the treating team.",[19,13],"Diagnostic Test: Biomarker-signature supported antibiotic treatment recommendation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Biomarker-signature supported antibiotic treatment recommendation","The antibiotic treatment recommendation will be based on a decision matrix that combines the results of the BV-signature (a score ranging from 0 -100) with the clinical assessment of likelihood of bacterial infection.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Clinical assessment for antibiotic treatment decision","Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)",[9,15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Makeda Semret, MD","CONTACT","15149341934","35081","makeda.semret@mcgill.ca",[39,56,67,74],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Montreal General Hospital","RECRUITING","Montreal","Quebec","H3G 1A4","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-73.58781,45.50884,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":26,"phoneExt":26,"email":37},"Makeda Semret, MD, FRCP(C)",{"facility":57,"status":41,"city":42,"state":43,"zip":58,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Research Institute of McGill University Health Center (RI-MUHC)","H4A 3J1",{"type":48,"coordinates":60},[50,51],{"lat":51,"lon":50},[63,65],{"name":64,"role":34,"phone":26,"phoneExt":26,"email":37},"MD, FRCP(C)",{"name":55,"role":66,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":68,"status":41,"city":42,"state":43,"zip":58,"country":45,"countryCode":46,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Royal Victoria Hospital",{"type":48,"coordinates":70},[50,51],{"lat":51,"lon":50},[73],{"name":55,"role":34,"phone":26,"phoneExt":26,"email":37},{"facility":75,"status":41,"city":42,"state":43,"zip":76,"country":45,"countryCode":46,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Research Institute McGill University Health Centre","H4A3J1",{"type":48,"coordinates":78},[50,51],{"lat":51,"lon":50},[81],{"name":33,"role":34,"phone":82,"phoneExt":36,"email":37},"5149341934",{"type":66,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Makeda Semret","Principal Investigator (NPA)",[87],{"name":88,"class":89},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100629984","biomarker-signature-supported-antibiotic-treatment-decisions-in-icu-100629984",false,"NCT07481773","Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU","Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units","BAST-ICU","Inclusion Criteria:\n\n* Admitted to the Intensive Care Unit (ICU)\n* Started on antibiotics for any suspected or confirmed infection in the preceding 72 hours (about 3 days)\n* Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making\n\nExclusion Criteria:\n\n* Severe immunocompromise\u002Fimmunosuppression\n\n  1. Congenital immunodeficiency\n  2. HIV with CD4 \\\u003C 20\n  3. Active chemotherapy and profound neutropenia (ANC \\\u003C 100) expected to last \\> 7 days;\n  4. solid organ or stem cell transplant within preceding 6 months AND active GVHD\n  5. Receiving high dose steroids (Pred \\> 20mg\u002Fday for \\> or = 2 weeks)\n* Advanced metastatic cancer irrespective of treatment\n* Palliative intent, death imminent and inevitable within 4 weeks\n* Antibiotic to be discontinued within 24h (ex. Prophylaxis)\n* Active infection diagnosed and treated with antibiotics within preceding 2 weeks\n* Previously included during the same hospitalization","ALL","18 Years",{"count":101,"type":102},1200,"ESTIMATED","INTERVENTIONAL",[105],"NA","The goal of this randomized clinical trial is to determine whether a biomarker-signature (BV) supported antibiotic treatment decision matrix can have a beneficial impact on antibiotic use and patient outcomes in an ICU population.",[108],"Intensive Care Unit (ICU) Admission",[110,111,112],"ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device","Antimicrobial Stewardship","Antimicrobial Resistance","2026-03-14",{"date":115,"type":116},"2026-03-19","ACTUAL",{"date":118,"type":116},"2025-05-13",{"date":120,"type":102},"2028-08",{"name":5,"class":6},4]