[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rifampicin-resistant-tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rifampicin-resistant-tuberculosis":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,89,116,146,176],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100644919","phase-3-a-6-month-mdr-end-plus-regimen-for-rifampicin-resistant-tuberculosis-100644919",false,"NCT07675954","A 6-Month MDR-END Plus Regimen for Rifampicin-Resistant Tuberculosis","A Phase 3, Open-Label, Randomised Controlled Trial to Evaluate a 6-Month \"MDR-END Plus\" Regimen (Bedaquiline, Delamanid, Delpazolid, Levofloxacin and Pyrazinamide) Versus the South African Standard of Care Treatment for Rifampicin-Resistant Tuberculosis","MDR-ENDPlus","Inclusion Criteria:\n\n1. Willing and able to voluntarily provide written informed consent to participate in the study prior to initiation of any study-related procedures. For participants under the age of 18 years, signed consent may be obtained from the child's biological parent, legal guardian, or primary caregiver in the presence of the child. Minor participants must also be willing to provide written assent for study participation.\n2. To the best of their knowledge and abilities at screening, participants must be willing and able to adhere to the complete follow-up schedule and all study procedures.\n3. Male or female participants aged 15 years or older.\n4. Participant requires treatment for pulmonary rifampicin-resistant tuberculosis based on one or more of the following:\n\n   * Documented molecular drug susceptibility testing, such as TB nucleic acid amplification test, line probe assay, targeted next-generation sequencing, or culture-based phenotypic drug susceptibility testing on a sample obtained from the participant within 8 weeks prior to screening, even if rifampicin resistance is not re-confirmed on a sample obtained at screening; or\n   * Documented or self-reported clinical symptoms or signs of pulmonary tuberculosis disease, with or without radiological changes consistent with pulmonary tuberculosis, and evidence of close contact with someone with confirmed rifampicin-resistant tuberculosis which, in the opinion of the site investigator, indicates significant exposure and a clinical decision has been made to treat the participant for rifampicin-resistant tuberculosis in routine care; or\n   * Documented peripheral tuberculosis lymphadenitis or tuberculosis pleurisy with confirmed rifampicin-resistant Mycobacterium tuberculosis on lymph node biopsy or pleural fluid aspiration, along with documented symptoms or signs suggestive of pulmonary tuberculosis without culture confirmation.\n5. Not yet started rifampicin-resistant tuberculosis treatment, or initiated rifampicin-resistant tuberculosis treatment in routine care within 10 days prior to enrolment.\n6. Body weight of at least 30 kg.\n7. Documented HIV status and\u002For willing to undergo HIV testing.\n8. Participants living with HIV must be on antiretroviral therapy, or due to start antiretroviral therapy within 2 months of enrolment, regardless of CD4 count, provided they are clinically stable in the opinion of the site investigator.\n9. Pregnant women in any trimester and breastfeeding women are eligible for inclusion.\n\nExclusion Criteria:\n\n1. Two or more of the following four drug groups cannot be used: bedaquiline or clofazimine; delamanid or pretomanid; linezolid or delpazolid; levofloxacin or moxifloxacin, due to any of the following:\n\n   * Documented Mycobacterium tuberculosis resistance in the current or prior treatment episode;\n   * Prior exposure of 1 month or longer, unless protocol-defined exceptions are met;\n   * Absolute contraindications to the relevant study drugs;\n   * Use of prohibited concomitant medications within 14 days prior to enrolment.\n2. Ongoing treatment for rifampicin-resistant tuberculosis for more than 10 days in the current tuberculosis episode.\n3. Isolated extrapulmonary tuberculosis without pulmonary involvement.\n4. Extrapulmonary tuberculosis, with or without concurrent pulmonary tuberculosis, involving the central nervous system, osteoarticular sites, pericardium, or disseminated\u002Fmiliary disease.\n5. Any of the following laboratory or ECG abnormalities:\n\n   A. Alanine transaminase or aspartate transaminase \\>120 U\u002FL; B. Total bilirubin \\>2.4 mg\u002FdL; C. Estimated glomerular filtration rate by the CKD-EPI equation \\\u003C30 mL\u002Fmin\u002F1.73 m²; D. Serum potassium \\\u003C3.2 mmol\u002FL; E. QTcF \\>480 msec.\n6. Atrioventricular block, second or third degree; current or previous history of clinically significant ventricular arrhythmias or long QT syndrome; or family history of long QT syndrome or sudden cardiac death.\n7. Any condition or circumstance which, in the opinion of the investigator, based on information available at the time of screening, raises concerns regarding the participant's safety or ability to participate in the trial or the integrity of the study data.","ALL","15 Years",{"count":20,"type":21},294,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.\n\nThe goal of this clinical trial is to learn whether a 6-month MDR-END Plus regimen works as well as current standard of care (SoC) treatment for rifampicin-resistant tuberculosis. The trial will also learn whether the MDR-END Plus regimen is safer and easier to tolerate than SoC regimens.\n\nThe main questions this trial aims to answer are:\n\n* Does the MDR-END Plus regimen lead to a favorable treatment outcome 12 months after treatment is stopped, compared with SoC regimens?\n* Do participants receiving the MDR-END Plus regimen have fewer important safety or tolerability problems during treatment and up to 90 days after treatment is stopped, compared with SoC regimens?\n\nResearchers will compare the MDR-END Plus regimen with South African standard of care (SoC) treatment for rifampicin-resistant tuberculosis.\n\nParticipants will:\n\n* Be randomly assigned to receive either the MDR-END Plus regimen or SoC treatment.\n* Take tuberculosis medicines for about 6 months, although treatment may be extended in some cases.\n* Attend study visits during treatment and after treatment is stopped.\n* Have clinical assessments, blood tests, heart tracing tests, vision and nerve assessments, and tuberculosis tests.\n* Be followed for 12 months after treatment is stopped.",[27],"Rifampicin-Resistant Tuberculosis",[29,30,31,32,33,34,35,36,37,38,39,40],"Rifampicin-resistant tuberculosis","Multidrug-resistant tuberculosis","MDR-TB","RR-TB","Bedaquiline","Delamanid","Delpazolid","Levofloxacin","Pyrazinamide","MDR-END Plus","Short treatment regimen","South Africa","NOT_YET_RECRUITING","2026-06-23",{"date":44,"type":45},"2026-06-30","ACTUAL",{"date":47,"type":21},"2026-10-01",{"date":49,"type":21},"2032-06",{"name":51,"class":52},"Seoul National University Hospital","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":53},"100623192","phase-2-acetohydroxamic-acid-combined-with-a-short-course-regimen-for-mdr-tb-aha-plus-100623192","NCT07393438","Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)","Acetohydroxamic Acid Combined With a Short-Course Regimen for the Treatment of Multidrug-Resistant Tuberculosis: A Phase II Clinical Trial","AHA-PLUS","Inclusion Criteria:\n\n* Age 14 to \\\u003C 65 years, male or female\n* Confirmed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) by molecular testing (e.g., Xpert MTB\u002FRIF) or drug susceptibility testing\n* Positive sputum culture for Mycobacterium tuberculosis or positive molecular test\n* Chest imaging consistent with active pulmonary TB, or histologically confirmed extrapulmonary TB (excluding CNS, osteoarticular, and disseminated TB)\n* Body weight ≥ 40 kg\n* Karnofsky Performance Status ≥ 50\n* Adequate laboratory parameters:\n\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * ANC ≥ 1000\u002Fmm³\n  * Platelets ≥ 75,000\u002Fmm³\n  * ALT\u002FAST ≤ 3 × ULN\n  * Total bilirubin ≤ 2 × ULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n* QTcF interval \\\u003C 450 ms (male) or \\\u003C 470 ms (female)\n* HIV-negative, confirmed by approved testing\n* No prior exposure to bedaquiline, delamanid, or linezolid for more than 1 month\n* Female participants of childbearing potential must agree to use effective contraception and have a negative pregnancy test\n* Signed informed consent\n\nExclusion Criteria:\n\n* Central nervous system TB (e.g., TB meningitis), osteoarticular TB, or disseminated\u002Fmiliary TB\n* Known allergy or serious adverse reaction to any study drug or background regimen component\n* Known resistance to bedaquiline, delamanid, or linezolid\n* Use of anti-TB drugs within the past 30 days that may interfere with study assessments, except in documented treatment failure cases\n* Severe comorbidities, including:\n\n  * NYHA Class III-IV heart failure\n  * History or risk factors for Torsades de Pointes\n  * Child-Pugh B or C cirrhosis\n  * Uncontrolled diabetes (HbA1c \\> 10%)\n  * Active malignancy\n* Current use of QT-prolonging medications that cannot be substituted\n* Current use of MAO inhibitors or serotonergic drugs\n* BMI \\\u003C 17 kg\u002Fm² with severe malnutrition\n* Grade 3-4 peripheral neuropathy at baseline\n* Pregnant or breastfeeding women\n* Any condition that, in the investigator's judgment, may interfere with study completion or data interpretation","18 Years","65 Years",{"count":65,"type":21},120,[67],"PHASE2","This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug-resistant tuberculosis (MDR-TB).\n\nThe primary objectives are to assess the safety and tolerability of AHA combined with short-course regimens, and to determine the recommended phase II dose (RP2D) of AHA.\n\nThe secondary objectives include evaluating the 8-week sputum culture conversion rate, pharmacokinetic parameters, and exploring DNA damage repair biomarkers as potential indicators of treatment response.",[70,71,31,32],"Multidrug-Resistant Tuberculosis","Rifampicin-resistant Tuberculosis",[73,74,75,76,77,78,79],"Acetohydroxamic Acid","Short-Course Regimen","BDLLfxC","BDCZ","DNA Repair","RP2D","Phase II","2026-01-31",{"date":82,"type":45},"2026-02-06",{"date":84,"type":21},"2026-02-21",{"date":86,"type":21},"2028-11-30",{"name":88,"class":52},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100606073","phase-2-a-phase-2b-clinical-study-of-jdb0131-benzenesulfonate-tablets-100606073","NCT07170800","A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets","A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)","Inclusion Criteria:\n\n* Age: 14 years through 65 years of age, male or female\n* Weight: 40kg ≤ weight ≤ 90kg\n* Patients with clinically confirmed pulmonary tuberculosis, Drug Susceptibility Testing (DST) results confirmed to be at least rifampicin-resistant, molecular or phenotypic DST results within 3 months before enrollment can be received\n* Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)\n* Patients who are currently taking anti-tuberculosis treatment or using drugs with anti-tuberculosis effects agree to stop all anti-tuberculosis drug treatment and complete a 7-day washout period\n* Women of reproductive age must agree to use highly effective contraceptive measures throughout the study and for at least 6 months after discontinuation of the drug. Male participants whose partners are women of reproductive age must agree to use appropriate contraceptive methods throughout the study and for at least 6 months after discontinuation of the drug (see protocol Appendix 1)\n* Fully understand the purpose and requirements of this trial, voluntarily sign the written informed consent and agree to abide by the relevant provisions of the informed consent\n\nExclusion Criteria:\n\n* Those who cannot take delamanid, bedaquiline, or linezolid for various reasons\n* Take delamanid, bedaquiline, or linezolid for more than 1 month (can be enrolled if evidence of no resistance to the above drugs is provided)\n* Hematogenously disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator; or patients with pulmonary tuberculosis who are assessed by the investigator to be likely to require surgical treatment within 8 weeks\n* History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia\n* Anyone with any of the following cardiovascular diseases or other conditions within 6 months before enrollment:\n\n  1. Myocardial infarction;\n  2. Heart surgery or coronary revascularization (coronary artery bypass grafting\u002Fpercutaneous transluminal coronary angioplasty);\n  3. Unstable angina;\n  4. Congestive heart failure (New York Heart Association functional class III or IV);\n  5. Transient ischemic attack or severe cerebrovascular disease.\n* Peripheral neuropathy CTCAE grade 3 or 4; Grade 1 or 2 peripheral neuropathy that the investigator judges may progress\u002Fworsen during the study; Patients with optic neuritis\n* History of gastrointestinal surgery or resection that may affect the absorption and\u002For excretion of oral medications\n* Patients who are considered by the investigator to be unsuitable for this trial due to unstable or severe cardiovascular, renal, hepatic, blood, tumor, endocrine metabolic, psychiatric or rheumatic diseases\n* History of alcohol dependence or drug abuse within 6 months before screening, the investigator believes that it may affect the safety of the participants and affect the trial compliance\n* Patients who have used other clinical trial investigational drugs within 3 months before administration\n* Concomitant take drugs that cause bone marrow suppression\n* Concomitant take serotonin reuptake inhibitors, tricyclic antidepressants, serotonin, serotonin receptor agonists, and other drugs\n* Concomitant take drugs that prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, etc.\n* Chronic systemic corticosteroid therapy, cumulative take for more than 4 weeks within 3 months before enrollment\n* Allergic to any investigational drug or related substance as confirmed by the researcher's clinical judgment\n* Women who have a positive pregnancy test during screening or are breastfeeding\n* Patients with hepatitis B virus (HBV) positive results (HBsAg, HBeAg, and HBcAb); positive hepatitis C virus (HCV) antibodies and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \\>3 times the upper limit of normal; positive Human Immunodeficiency Virus (HIV) antibody test; positive syphilis antibody test and active syphilis\n* Laboratory tests show any of the following:\n\n  1. Hemoglobin \\\u003C 80 g\u002FL;\n  2. platelets \\\u003C 75 ✕ 109 \u002FL;\n  3. Aspartate aminotransferase (AST) \\> 3 times the upper limit of normal;\n  4. Alanine aminotransferase (ALT) \\> 3 times the upper limit of normal;\n  5. Serum total bilirubin (TBIL) \\> 2 times the upper limit of normal;\n  6. Serum creatinine (Cr) \\> 1.5 times the upper limit of normal;\n  7. Serum amylase \\> 2 times the upper limit of normal.\n* The following abnormalities were found in the electrocardiogram (ECG):\n\n  1. At least twice QTcF intervals \\> 450 ms (male) or \\> 470 ms (female);\n  2. Pathological Q waves (defined as \\>40 ms or deep \\>0.4-0.5mV);\n  3. ECG suggests preexcitation syndrome;\n  4. ECG suggests left bundle branch block or right bundle branch block; or second or third degree heart block;\n  5. Intraventricular conduction delay with QRS duration \\>120ms;\n  6. Bradycardia with a sinus rate \\\u003C 50 bpm.\n* In the investigator's judgment, any condition that affects the subject's compliance with the study protocol, or any serious medical or psychological condition that may affect the interpretation of efficacy and safety data, or any condition that may affect the subject's safety when participating in the trial","14 Years",{"count":98,"type":21},60,[67],"This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)\u002Fclofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.",[102,103,71],"Tuberculosis","Multidrug Resistant Pulmonary Tuberculosis","RECRUITING","2026-01-27",{"date":107,"type":45},"2026-01-30",{"date":109,"type":45},"2025-09-19",{"date":111,"type":21},"2026-09-04",{"name":113,"class":114},"WestVac Biopharma Co., Ltd.","INDUSTRY",7,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"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":65,"type":21},[24],"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.",[128,129,102,130],"Rifampicin Resistant Tuberculosis","Pulmonary Tuberculosis","Drug-resistant Tuberculosis",[132,133,134,135],"drug-resistant tuberculosis","all-oral regimen","9 month regimen","tuberculosis","2025-11-26",{"date":138,"type":45},"2025-12-08",{"date":140,"type":21},"2025-12-01",{"date":142,"type":21},"2028-08-31",{"name":144,"class":52},"Beijing Chest Hospital",3,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100445512","phase-3-innovatingin-shorters-all--oral-precisedp-individualizedi-treatment-regimenre-for-rifampicin-resistant-tuberculosisinspire-tb-100445512","NCT05081401","Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)","INSPIRE-TB","Inclusion Criteria:\n\n1. Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;\n2. Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;\n3. Signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;\n2. Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;\n3. Patients known to be pregnant or breastfeeding at the time of enrollment;\n4. Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;\n5. Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.","16 Years","75 Years",{"count":156,"type":21},1050,[24],"The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones",[160,128,161],"Multidrug Resistant Tuberculosis","Pre-XDR-TB",[163,164,133,165],"multidrug resistant tuberculosis","shorter treatment","PZA sensitivity","2025-04-01",{"date":168,"type":45},"2025-04-06",{"date":170,"type":45},"2022-05-23",{"date":172,"type":21},"2027-12-01",{"name":174,"class":52},"Huashan Hospital",5,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":183,"targetDuration":185,"studyType":186,"phases":4,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100559567","french-national-cohort-of-patients-with-rifampicin-resistant-tuberculosis-100559567","NCT06565806","French National Cohort of Patients With Rifampicin-Resistant Tuberculosis","CONTRol-TB","Inclusion Criteria:\n\nPatient treated for MDR\u002FRR tuberculosis\n\n* In the major reference centres in the Paris region (CHU Pitié-Salpêtrière and Bichat \\[Paris\\], CH Bligny \\[Briis-sous-Forges\\]) for the retrospective part;\n* Throughout France (national register) for the prospective part.\n\nExclusion Criteria:\n\n* None",{"count":184,"type":21},300,"5 Years","OBSERVATIONAL","A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment. In 2021, only 60% of patients with MDR\u002FRR tuberculosis who received treatment globally were successfully cured, while 12% succumbed to the disease and 10% experienced treatment failure.\n\nIn France, a recent study by the National Reference Centre for Mycobacteria showed that while MDR\u002FRR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68% of cases, 30% were lost. The main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli, as well as the factors influencing these outcomes. Additionally, it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France.\n\nA national longitudinal cohort will be develop to study multidrug-resistant tuberculosis in France. The cohort includes a historical retrospective part from 2006-2019 and a prospective part from 2020, with planned inclusions until 2029. The restrospective cohort includes 298 patients from 2006-2019 and 178 patients from the CNR mycobacteria national registry until 2024. As for the prospective cohort arm, a projected total of roughly 300 patients will be included over the period from 2020 to 2029. Non-identifying clinical data will be derived exclusively from patients medical records at three expert centres in the Paris region for the restrospective cohort and throughout France (national register) for the prospective cohorte. For the retropective cohorte each centers will transcribe pseudonymised clinical data into secure Excel files, while the prospective cohort will enter non-identifying data directly into the national register using a secure platform overseen by the CNR of Mycobactéria.\n\nRegistry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator. Statistical analyses will include descriptive analyses of continuous and categorical variables, comparisons between subgroups using appropriate tests (Student's t, Mann-Whitney, Chi Square, Fisher), and logistic regressions to identify variables associated with treatment outcomes. P value \\\u003C 0.05 will be considered statistically significant",[71],[102,190],"Rifampicin-resistant","2024-08-19",{"date":193,"type":45},"2024-08-22",{"date":195,"type":21},"2024-09-01",{"date":197,"type":21},"2032-09-01",{"name":199,"class":52},"Assistance Publique - Hôpitaux de Paris"]