[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629984":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":82,"collaborators":85,"id":89,"slug":26,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":26,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"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",[39,55,66,73],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Montreal General Hospital","RECRUITING","Montreal","Quebec","H3G 1A4","Canada",{"type":47,"coordinates":48},"Point",[49,50],-73.58781,45.50884,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":26,"phoneExt":26,"email":37},"Makeda Semret, MD, FRCP(C)",{"facility":56,"status":41,"city":42,"state":43,"zip":57,"country":45,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Research Institute of McGill University Health Center (RI-MUHC)","H4A 3J1",{"type":47,"coordinates":59},[49,50],{"lat":50,"lon":49},[62,64],{"name":63,"role":34,"phone":26,"phoneExt":26,"email":37},"MD, FRCP(C)",{"name":54,"role":65,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":67,"status":41,"city":42,"state":43,"zip":57,"country":45,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Royal Victoria Hospital",{"type":47,"coordinates":69},[49,50],{"lat":50,"lon":49},[72],{"name":54,"role":34,"phone":26,"phoneExt":26,"email":37},{"facility":74,"status":41,"city":42,"state":43,"zip":75,"country":45,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Research Institute McGill University Health Centre","H4A3J1",{"type":47,"coordinates":77},[49,50],{"lat":50,"lon":49},[80],{"name":33,"role":34,"phone":81,"phoneExt":36,"email":37},"5149341934",{"type":65,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Makeda Semret","Principal Investigator (NPA)",[86],{"name":87,"class":88},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","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":99,"type":100},1200,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106],"Intensive Care Unit (ICU) Admission",[108,109,110],"ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device","Antimicrobial Stewardship","Antimicrobial Resistance","2026-03-14",{"date":113,"type":114},"2026-03-19","ACTUAL",{"date":116,"type":114},"2025-05-13",{"date":118,"type":100},"2028-08",{"name":5,"class":6},4]