[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481763":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":55,"collaborators":57,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":18,"maxAge":18,"enrollmentInfo":83,"targetDuration":18,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":18,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequencing Intervention in addition to standard of care","EXPERIMENTAL","Batched targeted deep sequencing in addition to the locally accepted standard of care drug susceptibility determination of multidrug\u002Fextensively drug-resistant tuberculosis (M\u002FXDR-TB)",[13],"Diagnostic Test: Targeted next-generation sequencing",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Locally accepted standard of care which is consistent with the WHO recommendations for the drug susceptibility determination of M\u002FXDR-TB",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","Targeted next-generation sequencing","During intervention periods, an additional patient sample derived from routinely collected specimens will be processed by a local technician. Extracted DNA extracted from these samples will be batched on a regular basis for targeted deep sequencing. Sequencing results will be regularly transmitted to a clinical advisory committee.",[9],[26],{"name":27,"affiliation":5,"role":28},"John Z Metcalfe, MD, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+14152068314","john.metcalfe@ucsf.edu",{"name":35,"role":31,"phone":18,"phoneExt":18,"email":18},"Rob Warren, PhD",[37],{"facility":38,"status":39,"city":40,"state":18,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"South African National Health Laboratory Service","RECRUITING","Cape Town","South Africa","ZA",{"type":44,"coordinates":45},"Point",[46,47],18.42322,-33.92584,{"lat":47,"lon":46},[50,52],{"name":51,"role":31,"phone":18,"phoneExt":18,"email":18},"Robin M Warren, PhD",{"name":53,"role":31,"phone":18,"phoneExt":18,"email":54},"Nabila Ismail, PhD","nabilai@sun.ac.za",{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[58,60,63,65,68,70,72],{"name":59,"class":6},"University of Stellenbosch",{"name":61,"class":62},"National Health Laboratory Service (NHLS), South Africa","UNKNOWN",{"name":64,"class":6},"National Institute for Communicable Diseases, South Africa",{"name":66,"class":67},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":69,"class":6},"Find",{"name":71,"class":6},"Translational Genomics Research Institute",{"name":73,"class":6},"University Hospital Heidelberg","100481763","pragmatic-use-of-next-generation-sequencing-for-management-of-drug-resistant-tuberculosis-100481763",false,"NCT05553236","Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis","Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis","TSELiOT","Inclusion Criteria:\n\n1. Active RR-TB diagnosed at a study facility during the study period\n2. Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)\n\nExclusion Criteria:\n\n1. Patient expects to relocate\u002Fmove residence outside of the study region\n2. Patient does not agree to participate in the study\n\nIn addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.","ALL",{"count":84,"type":85},2500,"ESTIMATED","INTERVENTIONAL",[88],"NA","TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.",[91,92,93],"Drug-resistant Tuberculosis","HIV Coinfection","Cost-Benefit Analysis","2026-01-22",{"date":96,"type":97},"2026-01-26","ACTUAL",{"date":99,"type":97},"2024-08-01",{"date":101,"type":85},"2027-01",{"name":5,"class":6},1]