[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561458":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":35,"responsibleParty":53,"collaborators":55,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":17,"enrollmentInfo":78,"targetDuration":17,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":38,"whyStopped":17,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Therapeutic Drug Monitoring (TDM)","Participants in the TDM arm will have their linezolid dose reduced if their trough concentration is greater than 2.5 mg\u002FL",[12],"Other: Therapeutic Drug Monitoring for Linezolid",{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of Care (SOC)","NO_INTERVENTION","Participants in the SOC arm will have their linezolid adjusted or held if they develop clinical adverse events.",null,[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":17},"Therapeutic Drug Monitoring for Linezolid","TDM with dose adjustment for trough concentration \\>2.5 mg\u002FL LZD",[9],[24,27],{"name":25,"affiliation":5,"role":26},"James CM Brust, MD","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Gary Maartens, MBChB","University of Cape Town",[31],{"name":25,"role":32,"phone":33,"phoneExt":17,"email":34},"CONTACT","718-920-6482","james.brust@einsteinmed.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Nkqubela TB Specialist Hospital","RECRUITING","East London","Eastern Cape","5206","South Africa","ZA",{"type":45,"coordinates":46},"Point",[47,48],27.91162,-33.01529,{"lat":48,"lon":47},[51,52],{"name":28,"role":32,"phone":17,"phoneExt":17,"email":17},{"name":28,"role":26,"phone":17,"phoneExt":17,"email":17},{"type":54,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[56,57,59,61,64,66],{"name":29,"class":6},{"name":58,"class":6},"St George's, University of London",{"name":60,"class":6},"Emory University",{"name":62,"class":63},"National Department of Health, South Africa","UNKNOWN",{"name":65,"class":6},"Columbia University",{"name":67,"class":68},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100561458","therapeutic-drug-monitoring-for-linezolid-in-the-treatment-of-rifampin-resistant-tuberculosis-100561458",false,"NCT06590428","Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis","THERMOL","Inclusion Criteria:\n\n* Adult male or female patient \\> 18 years of age\n* Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic or genotypic drug susceptibility testing, GeneXpert MTB\u002FRIF™). Participants may have resistance to additional medications as well - i.e., MDR and XDR TB - but must have resistance to at least rifampin\n* Initiated on a rifampicin-resistant tuberculosis (RR-TB) treatment regimen containing linezolid, no more than 14 days prior to randomization\n* HIV status is known and confirmed\n\n  * Both HIV-positive and HIV-negative individuals are eligible\n  * If an individual reports unknown HIV status, they must consent to HIV testing at time of enrollment to confirm status. If they decline to be tested, they are not eligible for the study\n\nExclusion Criteria:\n\n* Severe medical condition with expected death in the next 7 days\n* Pregnant at time of screening\n* Initial linezolid dose \\\u003C 600mg daily\n* Severe form of extrapulmonary TB (i.e., meningitis, pericarditis, or osteomyelitis)\n* Unlikely to follow-up at Nkqubela Hospital based on location of residence","ALL","18 Years",{"count":79,"type":80},280,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with Rifampicin-resistant tuberculosis (RR-TB). Following the initiation of treatment, participants will be monitored throughout the approximate 6-month duration of RR-TB therapy.",[86,87],"Rifampin-resistant Tuberculosis","Drug-resistant Tuberculosis",[89,90,91,92],"HIV Status","Therapeutic Drug Monitoring","anti-Tuberculosis activity","Linezolid","2026-04-28",{"date":95,"type":96},"2026-05-04","ACTUAL",{"date":98,"type":96},"2026-04-07",{"date":100,"type":80},"2029-12",{"name":5,"class":6},1]