[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433425":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":73,"centralContacts":77,"locations":86,"responsibleParty":257,"collaborators":259,"id":299,"slug":300,"hasResults":301,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":301,"sex":307,"minAge":308,"maxAge":34,"enrollmentInfo":309,"targetDuration":34,"studyType":312,"phases":313,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":89,"whyStopped":34,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Evaluation of various novel TB triage and diagnostic tests.","EXPERIMENTAL","For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB, with nested feasibility\u002Fpilot studies of early and late prototype tests. The investigators aim to enroll 300-450 participants per year at each of five enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability.",[13,14,15,16,17,18,19,20,21],"Diagnostic Test: Novel mycobacterial culture techniques","Diagnostic Test: Novel sputum smear microscopy techniques","Diagnostic Test: Sputum-based molecular assays","Diagnostic Test: Tongue swab-based molecular assays","Diagnostic Test: Urine LAM assays","Diagnostic Test: Blood-based host immune response assays","Diagnostic Test: Breath-based assays","Diagnostic Test: Artificial intelligence-based digital health tools","Diagnostic Test: Phage-based assays",{"label":23,"type":10,"description":24,"interventionNames":25},"Evaluation of novel rDST assays","Clinicians at participating sites will be asked to refer adult patients with rifampin-resistance identified by routine molecular testing. The investigators aim to enroll 100-200 patients per year at each of three enrollment sites for evaluation of novel rDST assays.",[26,27],"Diagnostic Test: Cartridge-based molecular assays for detecting drug resistance","Diagnostic Test: Sequencing-based assays for detecting drug resistance",[29,35,39,43,46,50,54,58,62,66,69],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIAGNOSTIC_TEST","Novel mycobacterial culture techniques","We will evaluate tests intended to make culture more sensitive, faster, and have less contamination.",[9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Novel sputum smear microscopy techniques","We will evaluate new staining techniques or visualization methods to increase the sensitivity of smear microscopy.",[9],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Sputum-based molecular assays","We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.",[9],{"type":30,"name":44,"description":41,"armGroupLabels":45,"otherNames":34},"Tongue swab-based molecular assays",[9],{"type":30,"name":47,"description":48,"armGroupLabels":49,"otherNames":34},"Urine LAM assays","We will evaluate urine LAM assays incorporating techniques such as analyte concentration, higher sensitivity or specificity antibodies, or enhanced visualization to improve LAM detection.",[9],{"type":30,"name":51,"description":52,"armGroupLabels":53,"otherNames":34},"Blood-based host immune response assays","We will evaluate assays measuring host immune response parameters intended for use at near point of care or point of care.",[9],{"type":30,"name":55,"description":56,"armGroupLabels":57,"otherNames":34},"Breath-based assays","We will evaluate assays assessing volatile organic compounds or exhaled breath condensate for near point of care of point of care detection of TB.",[9],{"type":30,"name":59,"description":60,"armGroupLabels":61,"otherNames":34},"Artificial intelligence-based digital health tools","We will evaluate AI-based algorithms evaluating images (chest x-ray, ultrasound) or sounds (cough sounds, lung sounds) including an Infrasound-to-ultrasound e-stethoscope (Level 42 AI, USA).",[9],{"type":30,"name":63,"description":64,"armGroupLabels":65,"otherNames":34},"Phage-based assays","We will evaluate assays using phages to lyse mycobacterial cells for detection of DNA or antigens.",[9],{"type":30,"name":67,"description":41,"armGroupLabels":68,"otherNames":34},"Cartridge-based molecular assays for detecting drug resistance",[23],{"type":30,"name":70,"description":71,"armGroupLabels":72,"otherNames":34},"Sequencing-based assays for detecting drug resistance","We will evaluate targeted and whole genome sequencing assays.",[23],[74],{"name":75,"affiliation":5,"role":76},"Adithya Cattamanchi, MD","PRINCIPAL_INVESTIGATOR",[78,82],{"name":75,"role":79,"phone":80,"phoneExt":34,"email":81},"CONTACT","+1-415-206-5489","adithya.cattamanchi@ucsf.edu",{"name":83,"role":79,"phone":84,"phoneExt":34,"email":85},"Catherine Cook, MPH","603-988-9940","catherine.cook@ucsf.edu",[87,103,117,124,131,145,159,173,180,187,194,201,215,222,236,243],{"facility":88,"status":89,"city":90,"state":34,"zip":34,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"National Center for Tuberculosis and Lung Diseases","RECRUITING","Tbilisi","Georgia","GE",{"type":94,"coordinates":95},"Point",[96,97],44.83412,41.69143,{"lat":97,"lon":96},[100],{"name":101,"role":79,"phone":34,"phoneExt":34,"email":102},"Nestani Tukvadze","Nestan Tukvadze \u003Cmarikushane@yahoo.com>",{"facility":104,"status":89,"city":105,"state":34,"zip":34,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Chitoor (Christian Medical College satellite campus)","Vellore","India","IN",{"type":94,"coordinates":109},[110,111],79.13255,12.9184,{"lat":111,"lon":110},[114],{"name":115,"role":79,"phone":34,"phoneExt":34,"email":116},"DJ Christopher","djchris@cmcvellore.ac.in",{"facility":118,"status":89,"city":105,"state":34,"zip":34,"country":106,"countryCode":107,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Christian Medical College CMC Pulmonary Outpatient Department",{"type":94,"coordinates":120},[110,111],{"lat":111,"lon":110},[123],{"name":115,"role":79,"phone":34,"phoneExt":34,"email":116},{"facility":125,"status":89,"city":105,"state":34,"zip":34,"country":106,"countryCode":107,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"Primary care clinics (Shalom\u002FLCC, CHAD)",{"type":94,"coordinates":127},[110,111],{"lat":111,"lon":110},[130],{"name":115,"role":79,"phone":34,"phoneExt":34,"email":116},{"facility":132,"status":89,"city":133,"state":34,"zip":34,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Zankli Research Center","Abuja","Nigeria","NG",{"type":94,"coordinates":137},[138,139],7.49508,9.05785,{"lat":139,"lon":138},[142],{"name":143,"role":79,"phone":34,"phoneExt":34,"email":144},"John Bimba, MD","john.bimba@binghamuni.edu.ng",{"facility":146,"status":89,"city":147,"state":34,"zip":34,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"De La Salle Medical and Health Sciences Institute","Dasmariñas","Philippines","PH",{"type":94,"coordinates":151},[152,153],120.93667,14.32944,{"lat":153,"lon":152},[156],{"name":157,"role":79,"phone":34,"phoneExt":34,"email":158},"Charles Yu","chrlsyu@yahoo.com",{"facility":160,"status":89,"city":161,"state":34,"zip":34,"country":162,"countryCode":163,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Brooklyn Chest Hospital","Cape Town","South Africa","ZA",{"type":94,"coordinates":165},[166,167],18.42322,-33.92584,{"lat":167,"lon":166},[170],{"name":171,"role":79,"phone":34,"phoneExt":34,"email":172},"Grant Theron","gtheron@sun.ac.za",{"facility":174,"status":89,"city":161,"state":34,"zip":34,"country":162,"countryCode":163,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"Khayelitsha District Health Center",{"type":94,"coordinates":176},[166,167],{"lat":167,"lon":166},[179],{"name":171,"role":79,"phone":34,"phoneExt":34,"email":172},{"facility":181,"status":89,"city":161,"state":34,"zip":34,"country":162,"countryCode":163,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Kraaifontein Community Health Clinic",{"type":94,"coordinates":183},[166,167],{"lat":167,"lon":166},[186],{"name":171,"role":79,"phone":34,"phoneExt":34,"email":172},{"facility":188,"status":89,"city":161,"state":34,"zip":34,"country":162,"countryCode":163,"cosmosGeoPoint":189,"geoPoint":191,"contacts":192},"Scottsdene primary care clinic",{"type":94,"coordinates":190},[166,167],{"lat":167,"lon":166},[193],{"name":171,"role":79,"phone":34,"phoneExt":34,"email":172},{"facility":195,"status":89,"city":161,"state":34,"zip":34,"country":162,"countryCode":163,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"Wallacedene primary care clinic",{"type":94,"coordinates":197},[166,167],{"lat":167,"lon":166},[200],{"name":171,"role":79,"phone":34,"phoneExt":34,"email":172},{"facility":202,"status":89,"city":203,"state":34,"zip":34,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Kisenyi Health Center","Kampala","Uganda","UG",{"type":94,"coordinates":207},[208,209],32.58219,0.31628,{"lat":209,"lon":208},[212],{"name":213,"role":79,"phone":34,"phoneExt":34,"email":214},"William Worodria","worodria@yahoo.com",{"facility":216,"status":89,"city":203,"state":34,"zip":34,"country":204,"countryCode":205,"cosmosGeoPoint":217,"geoPoint":219,"contacts":220},"Mulago Outpatient Department",{"type":94,"coordinates":218},[208,209],{"lat":209,"lon":208},[221],{"name":213,"role":79,"phone":34,"phoneExt":34,"email":214},{"facility":223,"status":89,"city":224,"state":34,"zip":34,"country":225,"countryCode":226,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Hanoi Lung Hospital, Outpatient departments","Hanoi","Vietnam","VN",{"type":94,"coordinates":228},[229,230],105.84117,21.0245,{"lat":230,"lon":229},[233],{"name":234,"role":79,"phone":34,"phoneExt":34,"email":235},"Nhung Nguyen","vietnhung@yahoo.com",{"facility":237,"status":89,"city":224,"state":34,"zip":34,"country":225,"countryCode":226,"cosmosGeoPoint":238,"geoPoint":240,"contacts":241},"National Lung Hospital, Outpatient departments",{"type":94,"coordinates":239},[229,230],{"lat":230,"lon":229},[242],{"name":234,"role":79,"phone":34,"phoneExt":34,"email":235},{"facility":244,"status":89,"city":245,"state":34,"zip":34,"country":246,"countryCode":247,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Centre for Infectious Disease Research in Zambia","Lusaka","Zambia","ZM",{"type":94,"coordinates":249},[250,251],28.28713,-15.40669,{"lat":251,"lon":250},[254],{"name":255,"role":79,"phone":34,"phoneExt":34,"email":256},"Monde Muyoyeta, Bsc, MBChB, PhD","monde.muyoyeta@cidrz.org",{"type":258,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[260,262,264,267,269,271,273,275,277,279,281,283,285,288,290,291,294,295,297],{"name":261,"class":6},"University Hospital Heidelberg",{"name":263,"class":6},"Christian Medical College, Vellore, India",{"name":265,"class":266},"Vietnam National Lung Hospital","UNKNOWN",{"name":268,"class":6},"De La Salle University Medical Center",{"name":270,"class":6},"University of Stellenbosch",{"name":272,"class":6},"Makerere University",{"name":274,"class":6},"Johns Hopkins Bloomberg School of Public Health",{"name":276,"class":6},"Harvard Medical School (HMS and HSDM)",{"name":278,"class":6},"Stanford University",{"name":280,"class":6},"Foundation for Innovative New Diagnostics, Switzerland",{"name":282,"class":6},"Socios En Salud Sucursal, Peru",{"name":284,"class":6},"Federal University of Mato Grosso",{"name":286,"class":287},"Medical Research Council","OTHER_GOV",{"name":289,"class":6},"National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia",{"name":244,"class":6},{"name":292,"class":293},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":132,"class":266},{"name":296,"class":6},"University of California, Irvine",{"name":298,"class":6},"Johns Hopkins University","100433425","rapid-research-in-diagnostics-development-for-tb-network-100433425",false,"NCT04923958","Rapid Research in Diagnostics Development for TB Network","Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study","R2D2TB Network","Novel TB triage and diagnostic tests:\n\nWe will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:\n\nPositive TB screening definitions by risk factor:\n\n1. PLHIV (Risk Factor), CRP \\>5 mg\u002FdL OR abnormal CXR (Positive TB screening definition)\n2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)\n3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)\n\nWe will exclude people who:\n\n1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);\n3. reside \\>20km from the study site or are unwilling to return for follow-up visits; or\n4. are unwilling to provide informed consent\n\nNovel TB rDST assays:\n\nWe will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB\u002FRIF, Xpert MTB\u002FRIF Ultra, or Hain MTBDRplus). We will exclude people who:\n\n1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures\n2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment\n3. are unable or unwilling to provide informed consent\n\nAssessment of the usability of novel TB tests:\n\nWe will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.","ALL","12 Years",{"count":310,"type":311},26436,"ESTIMATED","INTERVENTIONAL",[314],"NA","To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.",[317],"Tuberculosis",[317,319,320],"Diagnostics","Global Health","2026-05-04",{"date":323,"type":324},"2026-05-06","ACTUAL",{"date":326,"type":324},"2021-04-14",{"date":328,"type":311},"2031-05-31",{"name":5,"class":6},16]