[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645298":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":38,"studyPopulation":28,"armGroups":39,"interventions":52,"overallOfficials":28,"centralContacts":62,"locations":68,"responsibleParty":101,"collaborators":103,"id":113,"slug":28,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":28,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":28,"enrollmentInfo":121,"targetDuration":28,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":86,"whyStopped":28,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"I.M. Sechenov First Moscow State Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Frequency of etiotropic antibiotic therapy prescription","Proportion of patients receiving specific ABT within 14 days of diagnosis","14 days from the date of diagnosis",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"IE Complications requiring surgical treatment","Proportion of patients with IE-related complications (uncontrolled infection, heart failure, or embolic events) requiring surgical treatment during hospitalization","At discharge (an average of 14 days)",{"measure":19,"description":20,"timeFrame":17},"Acute Kidney Injury","Proportion of patients with acute kidney injury during hospitalization, defined as:\n\nincrease in serum creatinine by ≥26.5 μmol\u002FL within 48 hours, or increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, or urine output \\\u003C0.5 mL\u002Fkg\u002Fh for 6 hours.",{"measure":22,"description":23,"timeFrame":17},"ICU Transfer","Proportion of patients requiring transfer to the intensive care unit (ICU) during hospitalization (for admissions to non-ICU departments) or requiring repeated transfer to the ICU (if initially admitted to the ICU)",{"measure":25,"description":26,"timeFrame":27},"Mortality","Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method","30 days after diagnosis",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":34,"maskingDescription":35,"whoMasked":36},"SINGLE","Molecular test results are blinded for the treating physician, and blinded endpoint assessment is implemented (PROBE, participant randomization group will be blinded for the Endpoint Committee)",[37],"OUTCOMES_ASSESSOR","This is an open-label (with blinded endpoint assessment) multicenter randomized trial designed to evaluate the impact of an etiological diagnostic algorithm incorporating various laboratory methods (culture-based and molecular) on the frequency of etiological antibiotic therapy prescription within 14 days after the diagnosis of infective endocarditis. While molecular samples are collected from all participants, results are only disclosed to physicians in the intervention group to guide treatment, while remaining blinded in the control group.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Comprehensive Etiological Diagnosis Group","EXPERIMENTAL","Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy",[45],"Diagnostic Test: Molecular tests (PCR, sequencing)",{"label":47,"type":48,"description":49,"interventionNames":50},"Standard Clinical Practice Group","ACTIVE_COMPARATOR","Patients receive standard care; molecular test results are blinded for the treating physician",[51],"Diagnostic Test: Standard Clinical Practice",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":28},"DIAGNOSTIC_TEST","Molecular tests (PCR, sequencing)","PCR and PCR with consequent sequencing of the blood (or tissue) will be performed in addition to the cultural methods in the experimental study arm",[41],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":28},"Standard Clinical Practice","Patients receive standard care with analysis of microorganisms in at least 2 or more separate blood culture sets and from cardiac tissue (if surgical treatment is performed); molecular test results are blinded for the treating physician",[47],[63],{"name":64,"role":65,"phone":66,"phoneExt":28,"email":67},"Svetlana Rachina, Professor","CONTACT","+7 910 715-89-55","rachina_s_a@staff.sechenov.ru",[69,84,93],{"facility":70,"status":71,"city":72,"state":28,"zip":28,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health","NOT_YET_RECRUITING","Moscow","Russia","RU",{"type":76,"coordinates":77},"Point",[78,79],37.61781,55.75204,{"lat":79,"lon":78},[82],{"name":83,"role":65,"phone":28,"phoneExt":28,"email":28},"Dmitry Popov, Prof",{"facility":85,"status":86,"city":72,"state":28,"zip":28,"country":73,"countryCode":74,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"City Clinical Hospital Named After S. S. Yudin","RECRUITING",{"type":76,"coordinates":88},[78,79],{"lat":79,"lon":78},[91],{"name":92,"role":65,"phone":66,"phoneExt":28,"email":67},"Svetlana Rachina",{"facility":94,"status":86,"city":72,"state":28,"zip":28,"country":73,"countryCode":74,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"City Clinical Hospital №67 Named After L. A. Vorokhobova",{"type":76,"coordinates":96},[78,79],{"lat":79,"lon":78},[99],{"name":100,"role":65,"phone":28,"phoneExt":28,"email":28},"Svetlana Mirzakhamidova, Dr",{"type":102,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[104,107,109,111],{"name":105,"class":106},"Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor","UNKNOWN",{"name":108,"class":106},"City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation",{"name":110,"class":106},"City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation",{"name":112,"class":106},"A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation","100645298",false,"NCT07682389","Etiologic Diagnosis Algorithm in Infective Endocarditis","Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial","Inclusion Criteria:\n\n* Informed consent,\n* Age ≥ 18,\n* IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)\n\nExclusion Criteria:\n\n* Pregnancy\u002Fbreastfeeding\n* Unconfirmed or rejected IE diagnosis,\n* Very high risk of death within 14 days due to severe complications of the main or concomitant disease(s), according to the physician's opinion;\n* Prior use of antibiotic therapy (except documented treatment failure).","ALL","18 Years",{"count":122,"type":123},128,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this study is to evaluate the impact of a diagnostic algorithm combining culture-based and molecular methods on the frequency of etiotropic antibiotic therapy prescription within 14 days of diagnosis of infective endocarditis",[129,130],"Infective Endocarditis","Microbiology",[132,133,134,135,136],"Infective endocarditis","PCR","Antibiotic therapy","Etiological diagnosis","Sequencing","2026-06-28",{"date":139,"type":140},"2026-07-02","ACTUAL",{"date":142,"type":140},"2026-01-20",{"date":144,"type":123},"2027-02-20",{"name":5,"class":6},3]