[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562606":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pneumonia Panel","EXPERIMENTAL","The BIOFIRE®FILMARRAY® Pneumonia Panel is the only FDA approved mPCR test that can test 18bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses in one test within 45 minutes.\n\nUsing rapid diagnostic test to improve the proportion of antibiotics change, including escalation, de-escalation, discontinuation, or addition of antimicrobial medications in 24 hours within sample collection.",[13],"Diagnostic Test: The BIOFIRE®FILMARRAY® Pneumonia Panel",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Using current methods (empirical antibiotics) to treat patents with suspected bacterial infections.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DIAGNOSTIC_TEST","The BIOFIRE®FILMARRAY® Pneumonia Panel",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Chien-Chang Lee, Doctor of Science","CONTACT","+886-972-651-951","cclee100@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Yi-Tzu Lee, doctor","+886-920-610-054","s851009@yahoo.com.tw",[35],{"facility":5,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Taipei","Zhongzheng Dist","100","Taiwan","TW",{"type":42,"coordinates":43},"Point",[44,45],121.52639,25.05306,{"lat":45,"lon":44},[48,53],{"name":49,"role":27,"phone":50,"phoneExt":51,"email":52},"National Taiwan University Hospital Ethics Center Research Ethics Section","(02)2312-3456","263155","ntuhrec@ntuh.gov.tw",{"name":54,"role":27,"phone":55,"phoneExt":18,"email":56},"Taipei Veterans General Hospital The Medical Ethics Committee","(02)5568-8524","d3-mec@vghtpe.gov.tw",{"type":58,"investigatorFullName":59,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","National Taiwan University Clinical Trial Center",[61],{"name":62,"class":63},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV","100562606","clinical-impact-of-rapid-molecular-testing-for-pathogens-in-patients-with-severe-acute-respiratory-illness--a-pragmatic-trial-100562606",false,"NCT06605352","Clinical Impact of Rapid Molecular Testing for Pathogens in Patients With Severe Acute Respiratory Illness : A Pragmatic Trial","CIRT-RMT-SARI","Inclusion Criteria:\n\n1. Admitted to the ED\n2. Age ≥18 years old\n3. Diagnosis of SARI -modified from the World Health Organization definition:\n\n   * history of fever or measured fever of ≥ 38 C° and cough\n   * with onset within the last 10 days.\n   * requires hospitalization.\n   * with SpO2 on presentation less than 95% or respiratory rate more than 20 per minute, or requirement of intubation and mechanical ventilation.\n\nExclusion Criteria:\n\n1. Patients receiving palliative care\n2. Patients who declined sample collection\n3. Patients fail to provide written informed consent.\n4. Patients highly suspected or diagnosed pulmonary non-infectious disease (tumor, immune disease, etc) without evidence of infection.\n5. Patients diagnosed with COVID-19 within last 3 months.\n6. HIV-infected patients.\n7. Off work hour collected samples will be excluded from the study.\n8. Patients who died or being transitioned to comfort care within 48 hours of enrollment.\n\nStudy Population Description Inclusion criteria will be 1) ED patients age 18 or older; 2) presenting to the emergency department with acute severe respiratory illness. We define a case of severe acute respiratory illness (SARI) according to a previously suggested WHO case definition for all adults in whom onset of illness occurred within 7 days of admission. We defined SARI in adult as physician-diagnosed lower respiratory tract infection (LRTI) with SpO2 on presentation less than 95% or respiratory rate more than 20 per minute, or requirement of intubation and mechanical ventilation.\n\nSampling Method: random sampling","ALL","18 Years",{"count":74,"type":75},800,"ESTIMATED","INTERVENTIONAL",[78],"NA","Community-acquired pneumonia (CAP) is among the most common reasons for emergency department (ED) visits. A clear understanding of the likely pathogens is essential for the rapid institution of adequate antimicrobial therapy. Due to the indistinguishable clinical symptoms between viral and bacterial pathogens, patients with viral respiratory infection are usually under-evaluated while unnecessary antibacterial agents are more likely to be administered. With the development of highly sensitive end-to-end point-of-care (POC) multiplex PCR system, rapid diagnosis of respiratory pathogens for CAP in the ED becomes possible. Our previous NTUH-VGH cooperative research project demonstrated POC respiratory viral testing' in conjunction with procalcitonin test can reduce the length of hospital stay and antibiotic consumption. However, viral testing alone cannot guide precision antimicrobial treatment. A complete pneumonia pathogen testing panel should include bacteria, virus, atypical pathogens, and resistant genes. In addition, such test need to be completed within about time at a reasonable cost. The difficult missing has been recently achieved. The BIOFIRE®FILMARRAY® Pneumonia Panel is the only FDA approved mPCR test that can test 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses in one test within 45 minutes. Currently, the world is eagerly to learn how this new diagnostic technology can transform the clinical management of pneumonia. With this in mind, the aim of this study is to evaluate the impact of POC pneumonia pathognome wide testing on the antimicrobial use and outcome of patients. We will perform an open label pragmatic parallel comparison between patients with\u002Fwithout the test. The results will inform the pneumonia guideline. Subsequent health economic analysis based on this study will be important to the reimbursement policy of the health insurance of Taiwan.",[81,82],"Community-Acquired Pneumonia (CAP)","Pneumonia",[84,85,86,82,87,88],"Community-acquired pneumonia (CAP)","multiplex PCR","emergency department (ED)","Procalcitonin(PCT)","antimicrobial resistance","NOT_YET_RECRUITING","2024-09-18",{"date":92,"type":93},"2024-09-20","ACTUAL",{"date":92,"type":75},{"date":96,"type":75},"2026-12",{"name":59,"class":6},1]