[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521522":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":26,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MeMed BV® biomarker test and standard of care","EXPERIMENTAL","In addition to the standard of care for acute respiratory infections, the experimental arm shall reveal the results of the 'BV' test to the clinician co-investigators. The BV test reports a clinical score from 1-100 that as an adjunct to usual care, may help the clinician better direct appropriate resources towards the patient.",[13,14],"Diagnostic Test: MeMed BV® biomarker test","Diagnostic Test: Usual care",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual Care","ACTIVE_COMPARATOR","The co-investigators shall evaluate, diagnose and manage the acute respiratory infection presenting to the ED using the standard practice known in the community. This may include hospital sepsis practice protocols, clinical judgement, and national or local practice standards.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","MeMed BV® biomarker test","one purple top tube of whole blood (2-3 cc) to be used for the MeMed Key® device processing without the need for centrifuge. The MeMed BV® test takes approximately 15 minutes to process and result. After, the sample has been processed and the MeMed BV® test has resulted, the sample of blood will be discarded for each patient enrolled in the study.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual care","Usual care includes diagnostic hematology, chemistry, biomarkers, and culture results along with imaging, consults, and medications, in the treatment of acute viral and\u002For bacterial illness.",[9,16],[32],{"name":33,"affiliation":5,"role":34},"David Robinson, MD,MS,MMM","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","(713) 500-7873","David.J.Robinson@uth.tmc.edu",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Neomi Sepulveda","713.500.8474","Neomi.Sepulveda@uth.tmc.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,62],{"name":33,"role":37,"phone":61,"phoneExt":26,"email":39},"713-500-7873",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"David Robinson","Professor",[67],{"name":68,"class":69},"MeMed Diagnostics Ltd.","INDUSTRY","100521522","an-adjunct-test-distinguishing-bacterial-from-viral-etiology-improves-resource-utilization-and-efficiency-in-the-ed-100521522",false,"NCT06070688","An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.","Does an Adjunct Diagnostic Test That Can Discriminate Bacterial From Viral Etiology Early in the Management of Respiratory Infections Improve Management Accuracy and Quality in the Acute Care Setting?","Inclusion Criteria for main study population :\n\n* Current disease duration ≤ 7 days\n* Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days\n* Clinical suspicion of bacterial or viral respiratory tract infection (RTI)\n\nExclusion Criteria for main study population:\n\n* Systemic antibiotics taken up to 48 hours prior to presentation\n* Outpatient steroids taken within 48 hours prior to presentation\n* Suspicion and\u002For confirmed diagnosis of infectious gastroenteritis\u002Fcolitis\n* Inflammatory disease\n* Congenital immune deficiency (CID)\n* A proven or suspected infection on the presentation with Mycobacterial, parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen\n* Human immunodeficiency virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)\n* Major trauma and\u002For burns in the last 7 days\n* Major surgery in the last 7 days\n* Pregnancy - Self reported or medically confirmed\n* Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission.\n* Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days\n* Hemodynamically unstable (require life-saving interventions such as vasopressors)\n* Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)\n* Consider unsuitable for the study by the study team\n\nInclusion Criteria for Subgroup:\n\n* Written informed consent must be obtained from the patient or his\u002Fher legal guardian\n* Current disease duration ≤ 7 days\n* Clinical suspicion of bacterial or viral sepsis based on 2 or more SIRS criteria OR Clinical suspicion of bacterial or viral respiratory tract infection (RTI) AND temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days\n\nPatients fulfilling one or more of the following exclusion criteria from the main group are eligible for the subgroup cohort:\n\n* Systemic antibiotics taken up to 48 hours prior to presentation\n* Outpatient steroids taken within 48 hours prior to presentation\n* Suspicion and\u002For confirmed diagnosis of infectious gastroenteritis\u002Fcolitis\n* Inflammatory disease (e.g., IBD, SLE, RA, other vasculitis)\n* Congenital immune deficiency (CID)\n* A proven or suspected infection on the presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen\n* HIV, HBV, or HCV infection (self-declared or known from medical records)\n* Major trauma and\u002For burns in the last 7 days\n* Major surgery in the last 7 days\n* Pregnancy - Self reported or medically confirmed\n* Active malignancy of a solid tumor - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission\n* Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days\n* Hemodynamically unstable (require life-saving interventions such as vasopressors)\n* Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)","ALL","18 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS)",[87],"Respiratory Tract Infections",[89,90],"bacterial infection","viral infection","2026-01-21",{"date":93,"type":94},"2026-01-23","ACTUAL",{"date":96,"type":94},"2023-12-11",{"date":98,"type":81},"2026-12-31",{"name":5,"class":6},1]