[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659071":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":24,"overallOfficials":13,"centralContacts":30,"locations":37,"responsibleParty":232,"collaborators":13,"id":234,"slug":235,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":236,"sex":241,"minAge":13,"maxAge":13,"enrollmentInfo":242,"targetDuration":245,"studyType":246,"phases":13,"briefSummary":247,"conditions":248,"keywords":254,"overallStatus":104,"whyStopped":13,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"Deepull Diagnostics S.L.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)","Clinical performance of the UllCORE Bloodstream Infection (BSI) Test will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) compared with standard-of-care microbiological methods, as applicable. Performance will be evaluated for the microorganisms and antimicrobial resistance markers included in the test panel.","From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","The study population will consist of patients with suspected bloodstream infection (BSI) or sepsis who are undergoing standard-of-care blood culture testing. Participants will be recruited from Emergency Departments and Intensive Care Units.\n\nEligible patients will be identified based on clinical signs and symptoms consistent with suspected BSI or sepsis, such as fever, elevated inflammatory markers, hypotension, or other clinical findings prompting blood culture collection. Participants meeting the eligibility criteria will be enrolled prospectively and consecutively, without preference for specific demographic or clinical characteristics.",[19],{"label":20,"type":13,"description":21,"interventionNames":22},"Participants with Suspected Bloodstream Infection or Sepsis","Participants with suspected bloodstream infection or sepsis whose prospectively collected whole-blood specimens are either tested fresh using the investigational UllCORE Bloodstream Infection (BSI) Test or stored frozen before subsequent testing. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making.",[23],"Diagnostic Test: UllCORE BSI Test",[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":13},"DIAGNOSTIC_TEST","UllCORE BSI Test","The UllCORE Bloodstream Infection (BSI) Test is an investigational molecular diagnostic test designed to detect microorganisms and selected antimicrobial resistance markers directly from whole blood. In this study, prospectively collected whole blood specimens will be tested either fresh or after frozen storage, according to the study protocol. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making.",[20],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Roger Canton","CONTACT","936553530","+34","rcanton@deepull.com",[38,52,62,72,82,92,102,113,123,133,143,154,163,169,178,187,198,207,217,226],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":13},"University of California at Irvine Medical Center","NOT_YET_RECRUITING","Orange","California","92868","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.85311,33.78779,{"lat":50,"lon":49},{"facility":53,"status":40,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":13},"Tampa General Hospital","Tampa","Florida","33606",{"type":47,"coordinates":58},[59,60],-82.45843,27.94752,{"lat":60,"lon":59},{"facility":63,"status":40,"city":64,"state":65,"zip":66,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":71,"contacts":13},"The Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":47,"coordinates":68},[69,70],-76.61219,39.29038,{"lat":70,"lon":69},{"facility":73,"status":40,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":13},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":47,"coordinates":78},[79,80],-71.05977,42.35843,{"lat":80,"lon":79},{"facility":83,"status":40,"city":84,"state":85,"zip":86,"country":44,"countryCode":45,"cosmosGeoPoint":87,"geoPoint":91,"contacts":13},"Henry Ford Health","Novi","Michigan","48374",{"type":47,"coordinates":88},[89,90],-83.47549,42.48059,{"lat":90,"lon":89},{"facility":93,"status":40,"city":94,"state":95,"zip":96,"country":44,"countryCode":45,"cosmosGeoPoint":97,"geoPoint":101,"contacts":13},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":47,"coordinates":98},[99,100],-90.19789,38.62727,{"lat":100,"lon":99},{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":44,"countryCode":45,"cosmosGeoPoint":108,"geoPoint":112,"contacts":13},"University Hospitals Cleveland Medical Center","RECRUITING","Cleveland","Ohio","44106",{"type":47,"coordinates":109},[110,111],-81.69541,41.4995,{"lat":111,"lon":110},{"facility":114,"status":40,"city":115,"state":116,"zip":117,"country":44,"countryCode":45,"cosmosGeoPoint":118,"geoPoint":122,"contacts":13},"Geisinger Health","Danville","Pennsylvania","17822",{"type":47,"coordinates":119},[120,121],-76.61273,40.96342,{"lat":121,"lon":120},{"facility":124,"status":40,"city":125,"state":126,"zip":127,"country":44,"countryCode":45,"cosmosGeoPoint":128,"geoPoint":132,"contacts":13},"Vanderbilt health","Nashville","Tennessee","37232",{"type":47,"coordinates":129},[130,131],-86.78444,36.16589,{"lat":131,"lon":130},{"facility":134,"status":40,"city":135,"state":136,"zip":137,"country":44,"countryCode":45,"cosmosGeoPoint":138,"geoPoint":142,"contacts":13},"Baylor Scott & White Health Medical Center-Temple","Temple","Texas","76508",{"type":47,"coordinates":139},[140,141],-97.34278,31.09823,{"lat":141,"lon":140},{"facility":144,"status":40,"city":145,"state":13,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":13},"CHU de Limoges - Hôpital Dupuytren","Limoges","87000","France","FR",{"type":47,"coordinates":150},[151,152],1.24759,45.83362,{"lat":152,"lon":151},{"facility":155,"status":40,"city":156,"state":13,"zip":157,"country":147,"countryCode":148,"cosmosGeoPoint":158,"geoPoint":162,"contacts":13},"Hôpital de la Croix-Rousse - HCL","Lyon","69004",{"type":47,"coordinates":159},[160,161],4.84789,45.74906,{"lat":161,"lon":160},{"facility":164,"status":40,"city":165,"state":13,"zip":166,"country":167,"countryCode":168,"cosmosGeoPoint":13,"geoPoint":13,"contacts":13},"Charité - Campus Benjamin Franklin","Berlin-Zehlendorf","12203","Germany","DE",{"facility":170,"status":40,"city":171,"state":13,"zip":172,"country":167,"countryCode":168,"cosmosGeoPoint":173,"geoPoint":177,"contacts":13},"Universitaetsklinikum Jena","Jena","07443",{"type":47,"coordinates":174},[175,176],11.5899,50.92878,{"lat":176,"lon":175},{"facility":179,"status":40,"city":180,"state":13,"zip":181,"country":167,"countryCode":168,"cosmosGeoPoint":182,"geoPoint":186,"contacts":13},"Universitaetsklinikum Leipzig","Leipzig","04103",{"type":47,"coordinates":183},[184,185],12.37129,51.33962,{"lat":185,"lon":184},{"facility":188,"status":40,"city":189,"state":13,"zip":190,"country":191,"countryCode":192,"cosmosGeoPoint":193,"geoPoint":197,"contacts":13},"Azienda Ospedaliera Universitaria Careggi","Florence","50134","Italy","IT",{"type":47,"coordinates":194},[195,196],11.24626,43.77925,{"lat":196,"lon":195},{"facility":199,"status":40,"city":200,"state":13,"zip":201,"country":191,"countryCode":192,"cosmosGeoPoint":202,"geoPoint":206,"contacts":13},"Ospedale di Perugia Santa Maria della Misericordia","Perugia","06129",{"type":47,"coordinates":203},[204,205],12.38878,43.1122,{"lat":205,"lon":204},{"facility":208,"status":40,"city":209,"state":13,"zip":13,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":13},"Hospital Germans Trias I Pujol","Badalona","Spain","ES",{"type":47,"coordinates":213},[214,215],2.24741,41.45004,{"lat":215,"lon":214},{"facility":218,"status":40,"city":219,"state":13,"zip":220,"country":210,"countryCode":211,"cosmosGeoPoint":221,"geoPoint":225,"contacts":13},"Hospital Universitari Vall d'Hebron - VHIO","Barcelona","08035",{"type":47,"coordinates":222},[223,224],2.15899,41.38879,{"lat":224,"lon":223},{"facility":227,"status":40,"city":219,"state":13,"zip":228,"country":210,"countryCode":211,"cosmosGeoPoint":229,"geoPoint":231,"contacts":13},"Hospital Clínic de Barcelona","08036",{"type":47,"coordinates":230},[223,224],{"lat":224,"lon":223},{"type":233,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659071","evaluation-of-diagnostic-accuracy-and-clinical-performance-of-the-uiicore-bsi-test-100659071",false,"NCT07859852","Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test","B-RAPID","Inclusion Criteria:\n\n* Any age (where the remaining criteria can be safely fulfilled)\n* Ability to provide consent\u002Fassent in accordance with Institutional Review Board (IRB)\u002FEthics Committee (EC) determinations\n* The patient is presenting with signs and symptoms of suspected bloodstream infection (BSI) or fulfils the criteria for the hospital sepsis protocol.\n\nPlanned blood culture collection and laboratory analysis as per standard of care (SOC).\n\n• Patient is able and an appropriate candidate to be able to collect 2 K2 ethylenediaminetetraacetic acid (EDTA) tubes of whole blood.\n\nExclusion Criteria:\n\n* Unable to collect UllCORE BSI Test samples from the same venipuncture as blood culture (BC) samples\n* Patient was previously enrolled in the study","ALL",{"count":243,"type":244},1500,"ESTIMATED","30 Days","OBSERVATIONAL","This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis.\n\nParticipants enrolled in the study will have blood collected at the same time as blood samples obtained for standard-of-care blood culture testing. Study blood samples will be tested using the UllCORE BSI Test either as fresh samples or after frozen storage, according to the study protocol.\n\nThe results of the UllCORE BSI Test will be compared with standard-of-care microbiology results and, when applicable, additional testing methods to assess the diagnostic performance of the investigational test.\n\nThe UllCORE BSI Test results will not be used to guide patient care and will not be provided to treating healthcare professionals for clinical decision-making. Participation in the study will therefore not change the standard medical care received by participants.",[249,250,251,252,253],"Blood Stream Infection","Blood Stream Infections","Sepsis","Fungemia","Bacteremia",[255,256,257,258,259,260,261,262,263,264,265,27],"Bloodstream infection","Blood culture","Molecular diagnostics","Molecular diagnostic testing","Whole blood","Pathogen detection","Antimicrobial resistance markers","Rapid diagnostic testing","Sepsis diagnosis","Direct-from-blood testing","Multiplex polymerase chain reaction","2026-10-05",{"date":268,"type":269},"2026-10-08","ACTUAL",{"date":271,"type":269},"2026-09-21",{"date":273,"type":244},"2027-10",{"name":5,"class":6},20]