[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556893":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":123,"collaborators":7,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":7,"maxAge":7,"enrollmentInfo":134,"targetDuration":137,"studyType":138,"phases":7,"briefSummary":139,"conditions":140,"keywords":7,"overallStatus":144,"whyStopped":7,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Microbio Co Ltd","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","InfectID-BSI (Bloodstream Infection) qPCR Assay","InfectID-BSI technology targets nucleic acid sequences unique to the target analyte. The qPCR raw data collected from InfectID-BSI's 9 assay tubes is analysed by Microbio's InfectID-Client (InfectID-BSI-associated software) and the result is reported as an analyte-detection if the unique target analyte is present or no result if the unique target analyte is absent.\n\nInfectID-BSI is carried out with whole blood from a venous puncture (EDTA). DNA is extracted from a sample of the collected blood using a validated DNA extraction instrument according to the manufacturer's instructions. The extracted DNA is then added to the InfectID-BSI qPCR reagent panel which consists of 9 reaction tubes (6 for bacteria, and 3 for yeast species). The panel is subjected to real-time qPCR using a process of Melt Curve analysis using the Rotor-Gene Q MDx qPCR instrument. The assay report identifies the species present in the sample upon completion. Results are generated within 3 hours.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Naomi DeFazio","CONTACT","+61410661035","NDeFazio@microbio.com.au",[20,37,50,63,76,86,100,111],{"facility":21,"status":7,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Indiana University Hospital","Indianapolis","Indiana","46202","United States","US",{"type":28,"coordinates":29},"Point",[30,31],-86.15804,39.76838,{"lat":31,"lon":30},[34],{"name":15,"role":16,"phone":35,"phoneExt":7,"email":36},"3179445000","ndefazio@microbio.com.au",{"facility":38,"status":7,"city":39,"state":40,"zip":41,"country":25,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"University of Maryland","Baltimore","Maryland","21201",{"type":28,"coordinates":43},[44,45],-76.61219,39.29038,{"lat":45,"lon":44},[48],{"name":15,"role":16,"phone":49,"phoneExt":7,"email":36},"4107063100",{"facility":51,"status":7,"city":52,"state":53,"zip":54,"country":25,"countryCode":26,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"TriCore Reference Laboratories","Albuquerque","New Mexico","87102",{"type":28,"coordinates":56},[57,58],-106.65114,35.08449,{"lat":58,"lon":57},[61],{"name":15,"role":16,"phone":62,"phoneExt":7,"email":36},"5059388888",{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":25,"countryCode":26,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Vanderbilt University Medical Centre","Nashville","Tennessee","37232",{"type":28,"coordinates":69},[70,71],-86.78444,36.16589,{"lat":71,"lon":70},[74],{"name":15,"role":16,"phone":75,"phoneExt":7,"email":36},"6153225000",{"facility":77,"status":7,"city":78,"state":79,"zip":80,"country":25,"countryCode":26,"cosmosGeoPoint":81,"geoPoint":85,"contacts":7},"Texas Children's Hospital","Houston","Texas","77030",{"type":28,"coordinates":82},[83,84],-95.36327,29.76328,{"lat":84,"lon":83},{"facility":87,"status":7,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"The Prince Charles Hospital","Chermside","Queensland","4032","Australia","AU",{"type":28,"coordinates":94},[95,96],153.03062,-27.38472,{"lat":96,"lon":95},[99],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":36},{"facility":101,"status":7,"city":102,"state":89,"zip":103,"country":91,"countryCode":92,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"The Princess Alexandra Hospital","Woolloongabba","4102",{"type":28,"coordinates":105},[106,107],153.03655,-27.48855,{"lat":107,"lon":106},[110],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":36},{"facility":112,"status":7,"city":113,"state":7,"zip":7,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Southwest Regional Laboratory, UK Health Security Agency, Bristol UK","Bristol","United Kingdom","UK",{"type":28,"coordinates":117},[118,119],-2.59665,51.45523,{"lat":119,"lon":118},[122],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":36},{"type":124,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100556893","clinical-performance-study-of-microbio-infectid-bsi-for-detection-of-bacteria-and-yeast-with-patient-blood-samples-100556893",false,"NCT06531031","Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples","Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast","IID-BSIqPCR","Inclusion Criteria:\n\n* Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (≥18 years of age).\n* Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection.\n* Two additional EDTA blood sample\u002Fs collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible).\n* EDTA blood volume is ≥1mL.\n* EDTA blood sample is stored according to Microbio's stability requirements.\n\nExclusion Criteria:\n\n* No suspicion of blood stream infection (BSI).\n* Any inclusion criterion not met.\n* Multiple EDTA blood samples from the same patient.\n* EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample.\n* Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen.\n* EDTA blood samples that have not been stored according to Microbio's sample stability requirements.\n* EDTA blood volume \\\u003C1mL.","ALL",{"count":135,"type":136},1500,"ESTIMATED","1 Day","OBSERVATIONAL","The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture.\n\nThe objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.",[141,142,143],"Bloodstream Infection","Sepsis","Septic Shock","NOT_YET_RECRUITING","2025-07-20",{"date":147,"type":148},"2025-07-24","ACTUAL",{"date":150,"type":136},"2025-08",{"date":152,"type":136},"2026-11",{"name":5,"class":6},8]