[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-resistant-tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-resistant-tuberculosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,70,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Rifampin-resistant Tuberculosis","Drug-resistant Tuberculosis",[29,30,31,32],"HIV Status","Therapeutic Drug Monitoring","anti-Tuberculosis activity","Linezolid","RECRUITING","2026-04-28",{"date":36,"type":37},"2026-05-04","ACTUAL",{"date":39,"type":37},"2026-04-07",{"date":41,"type":20},"2029-12",{"name":43,"class":44},"Albert Einstein College of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100481763","pragmatic-use-of-next-generation-sequencing-for-management-of-drug-resistant-tuberculosis-100481763","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.",{"count":55,"type":20},2500,[23],"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.",[27,59,60],"HIV Coinfection","Cost-Benefit Analysis","2026-01-22",{"date":63,"type":37},"2026-01-26",{"date":65,"type":37},"2024-08-01",{"date":67,"type":20},"2027-01",{"name":69,"class":44},"University of California, San Francisco",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100613597","phase-3-innovating-shorter-all--oral-precised-treatment-regimen-for-rifampicin-resistant-tuberculosisblmz-chinese-cohort-100613597","NCT07268664","Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort","INSPIRE-BLMZ","Inclusion Criteria:\n\n* The participant (and their guardian if the participant lacks civil capacity) voluntarily signs the informed consent form (ICF) prior to enrollment.\n* The participant (and their guardian) indicates willingness to complete all steps and intervention periods of the study.\n* Male or female, aged ≥12 years, with a body weight ≥30 kilograms (kg).\n* Bacteriologically confirmed pulmonary tuberculosis, with molecular or phenotypic drug susceptibility testing (DST) results within the last 3 months confirming Rifampicin resistance and susceptibility to at least one of Moxifloxacin (MFX) or Levofloxacin (LFX).\n* Sputum or respiratory lavage fluid collected during the screening period is culture-positive for Mycobacterium tuberculosis, with DST results indicating Rifampicin resistance and susceptibility to at least one of MFX or LFX.\n* Females of childbearing potential are not pregnant (as confirmed by a negative pregnancy test), voluntarily agree to pregnancy testing, and are willing to use highly effective contraception from the time of ICF signing until 3 months after the end of study treatment.\n* For males of reproductive potential, use condoms or other methods to ensure effective contraception for their partner.\n* Females who are breastfeeding are willing to discontinue breastfeeding from the time of ICF signing until 3 months after the end of study treatment.\n* Voluntary acceptance of HIV testing; if the result is positive, voluntary acceptance of antiretroviral therapy.\n\nExclusion Criteria:\n\n* Previous treatment with any of the drugs Bedaquiline (BDQ) or Linezolid (LZD) for more than 30 days.\n* Concurrent hematogenous disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator.\n* Current use of medications prohibited by the study protocol, and the investigator judges that the priority of continuing said medication for patient benefit outweighs participation in this study.\n\n（Note: If the investigator judges that the benefit of participating in this study is higher and obtains the participant's consent, the prohibited medication should be discontinued with an adequate washout period before participation.）\n\n* Known history of hypersensitivity to any drug in the protocol.\n* Current participation in any other investigational drug clinical trial.\n* Presence of cardiovascular disease risk at screening:\n\n  1. QTcF interval \\>450 milliseconds (ms). (Note: If QTcF \\>450 ms is detected, one unscheduled visit during the screening period is allowed for re-assessment.)\n  2. History of clinically significant arrhythmia within 60 days prior to enrollment, which in the investigator's opinion may increase risk upon study participation.\n  3. Decompensated heart failure.\n  4. Grade 3 hypertension not at control target.\n  5. Abnormal thyroid function.\n  6. Abnormal serum calcium, magnesium, or potassium levels. (Note: Isolated electrolyte disturbances without underlying disease may be considered for re-screening after corrective treatment.)\n  7. Other conditions deemed by the investigator to pose a cardiovascular disease risk.\n* History of optic neuropathy or peripheral neuropathy, which in the investigator's opinion may progress\u002Fworsen during the study or is unsuitable for study participation.\n* Evidence of liver disease at screening:\n\n  1. Active viral hepatitis: Positive HBsAg, or positive HBeAg and HBV DNA, or positive HCV RNA test, accompanied by persistent or recurrent abnormal ALT.\n  2. Decompensated cirrhosis.\n* History of renal disease or renal disease-related manifestations at screening:\n\n  1. History of unstable or rapidly progressive renal disease.\n  2. Moderate\u002Fsevere renal impairment or end-stage renal disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²).\n  3. Serum creatinine (Cr) ≥133 μmol\u002FL (1.5 mg\u002FdL) for males, or Cr ≥124 μmol\u002FL (1.4 mg\u002FdL) for females.\n* Other laboratory abnormalities at screening:\n\n  1. Hemoglobin level \\\u003C 8.0 g\u002FdL.\n  2. Platelet count \\\u003C75,000 \u002Fmm³.\n  3. Absolute neutrophil count (ANC) \\\u003C1000 \u002Fmm³.\n  4. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN).\n  5. Total bilirubin \\>2 times ULN, or \\>1.5 times ULN accompanied by other abnormal liver enzymes.\n  6. Albumin \\\u003C30 g\u002FL.\n* Pregnant or breastfeeding.\n* Any other condition (e.g., severe psychiatric disorder, neurological condition, substance abuse) that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to adhere to the protocol.","12 Years",{"count":79,"type":20},120,[81],"PHASE3","The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older. The main questions it aims to answer are:\n\nWhat is the proportion of participants with a favorable outcome at 18 months after starting the BLMZ regimen? What is the safety profile of the BLMZ regimen, as measured by the incidence of Grade 3 or higher adverse events and serious adverse events during the treatment period? This is a single-arm study, so there is no comparison group. Researchers will compare the study results to historical data to see if the BLMZ regimen shows sufficient efficacy and safety in the Chinese population.\n\nParticipants will:\n\nUndergo screening tests to confirm eligibility, including tests for TB bacteria and drug resistance.\n\nReceive the BLMZ regimen (Bedaquiline, Linezolid, Moxifloxacin\u002FLevofloxacin, and Pyrazinamide) orally for 9 months.\n\nAttend regular clinic visits for safety assessments, medication refills, and tests (e.g., sputum tests, blood tests, ECG, CT scans) during the 9-month treatment period and then every 3 months during a 15-month post-treatment follow-up period until 24 months after starting the treatment.",[84,85,86,27],"Rifampicin Resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis",[88,89,90,91],"drug-resistant tuberculosis","all-oral regimen","9 month regimen","tuberculosis","NOT_YET_RECRUITING","2025-11-26",{"date":95,"type":37},"2025-12-08",{"date":97,"type":20},"2025-12-01",{"date":99,"type":20},"2028-08-31",{"name":101,"class":44},"Beijing Chest Hospital",3,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100490868","bring-bpal2me-trial-comparing-nurse-led-rr-tb-treatment-to-physician-led-rr-tb-treatment-100490868","NCT05671718","Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment","Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment in Primary Care to Physician-Led, Hospital-Based Outpatient RR-TB Treatment: A Cluster Randomized, Non-Inferiority Trial","Inclusion Criteria:\n\nCluster Inclusion Criteria:\n\nPrimary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following:\n\n1. within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces;\n2. willingness of provincial TB program managers and hospital leadership to participate;\n3. willingness of PCC nurse manager to participate;\n4. diagnosis of 10 or more RR-TB patients per year; and\n5. have access to necessary labs, X-ray and electrocardiogram (ECG) equipment.\n\nParticipant Inclusion Criteria:\n\nAdult participants aged 18 years of age and older, regardless of HIV status, who have a new RR-TB diagnosis, deemed willing and able to provide informed consent in one of the four most common SA languages \\[Zulu, Xhosa, Afrikaans, and English\\] will be eligible.\n\nParticipant Exclusion Criteria:\n\n1. any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care initiation (e.g., severe weakness, confusion, severe mental illness, symptomatic low blood pressure, severe shortness of breath, and temp \\>39.0);\n2. Hemoglobin \\\u003C 8mg\u002FdL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT \\> 120 U\u002FL);\n3. prolonged QTc\\>470ms, confirmed by 2 or more ecg;\n4. rapid heartrate, tachycardia (HR \\>140); confirmed after 5 minutes of rest;\n5. pregnancy;\n6. evidence of extrapulmonary disease;\n7. enrolled in another clinical trial that changes BPaL-L regimen, duration or symptom management process.",{"count":111,"type":20},2944,[23],"The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB treatment at district hospitals in the provinces of KwaZulu-Natal, Gauteng, and Eastern Cape.\n\nThe main aim is to conduct a 5-year, analyst and clinical safety review committee blinded, multi-site, cluster randomized trial to evaluate 1) treatment outcome; 2) safety; 3) patient associated catastrophic costs with the following hypotheses:\n\n1. Outpatient nurse-led treatment in PCCs will be non-inferior to outpatient physician-led treatment at hospital-based outpatient sites among RR-TB patients, regardless of HIV co-infection, as determined by a successful treatment outcome \\[H1\\].\n2. The proportion of SAEs identified will not significantly differ by blinded, independent review \\[H2\\].\n3. Patient associated catastrophic costs (i.e., costs 20% or more of household income) will be lower in nurse-led treatment \\[H3\\].",[115],"Drug Resistant Tuberculosis",[117,118,119,120,121,122,123,124],"nurse-led","non-inferiority cluster randomized trial","primary care","drug resistant tuberculosis","rifampicin resistant tuberculosis","human immunodeficiency virus","task sharing","South Africa","2025-10-15",{"date":127,"type":37},"2025-10-20",{"date":129,"type":37},"2023-09-04",{"date":131,"type":20},"2030-12-31",{"name":133,"class":44},"Johns Hopkins University",5]