[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-tuberculosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,41,72,108,140,162,189,220,242,273,294,326,356,396,424,445],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851",false,"NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.","ALL","18 Years",{"count":20,"type":21},315,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A5409\u002FRAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).\n\nA5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \\[(SOC) isoniazid\u002Frifampicin\u002Fpyrazinamide\u002Fethambutol (HRZE)\\].\n\nThe study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.",[27],"Pulmonary Tuberculosis","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2025-03-11",{"date":36,"type":21},"2027-08-11",{"name":38,"class":39},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100640904","artificial-intelligence-driven-tuberculosis-landscape-analysis--stratification-research-100640904","NCT07611695","Artificial Intelligence-driven Tuberculosis Landscape Analysis & Stratification Research","TB-ATLAS","Inclusion Criteria for Model Development Cohort:\n\n* Patient with clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (TB) who received TB treatment;\n* Initiation of TB treatment on or after January 1, 2021;\n* Complete key diagnosis and treatment data available in the electronic medical record system.\n\nInclusion Criteria for External Validation Cohort:\n\n* Patient with clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (TB) who is planning to start TB treatment;\n* Voluntary participation with signed informed consent form (for adults ≥18 years); parental \u002F guardian consent and co-signed informed consent form are required for minors aged ≤ 18 years.\n\nExclusion Criteria:\n\n* Co-morbidity confounding: the presence of other active, life-threatening disease (e.g. late-stage malignancy, non-HIV severe immunodeficiency) for which the expected survival or priority of treatment may substantially interfere with the attribution of TB treatment outcomes;\n* Extremely poor treatment adherence: documented evidence indicating that the patient either never initiated treatment or was permanently lost to follow-up within the early treatment period (\\\u003C2 weeks), precluding the collection of any valid outcome data.",{"count":49,"type":21},31600,"OBSERVATIONAL","The goal of this observational study is to establish and validate a comprehensive AI-driven clinical decision support system (AI-CDSS) in whole-chain management for pulmonary tuberculosis (TB) patients. The main question it aims to answer is:\n\nHow is the predictive performance of this system in terms of multiple key links during TB diagnosis and treatment? Can real-world benefits be derived from this system? This AI framework supports clinicians in making smarter decisions, ultimately improving cure rates and ensuring that every patient receives the most effective, personalized care possible.",[27,53,54],"Tuberculosis (TB)","Tuberculosis Active",[56,57,58,59],"tuberculosis","artificial intelligence","predictive model","clinical decision support system","NOT_YET_RECRUITING","2026-05-20",{"date":63,"type":32},"2026-05-28",{"date":65,"type":21},"2026-06-01",{"date":67,"type":21},"2028-06-30",{"name":69,"class":70},"Huashan Hospital","OTHER",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100609069","phase-3-a-study-of-quabodepistat-containing-regimens-for-the-treatment-of-drug-resistant-pulmonary-tuberculosis-100609069","NCT07209761","A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis","A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant\u002FMultidrug-resistant Pulmonary Tuberculosis","QUANTUM-TB","Inclusion Criteria:\n\n1. Age ≥14 years\n2. Body weight ≥30.0 kg\n3. Able to provide written informed consent (if under 18, requires both participant assent and parent\u002Fguardian consent)\n4. Documented pulmonary TB: Mtb confirmed by Xpert MTB\u002FRIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')\n5. Rifampicin resistance confirmed by Xpert MTB\u002FRIF Ultra test\n6. Chest radiograph consistent with active TB disease\n7. Able to provide sputum sample\n8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose\n9. Willing to have HIV test (unless previous positive result confirmed)\n10. For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine\u002Femtricitabine, tenofovir) for ≥3 months, Viral load \\\u003C200 copies\u002FmL, and CD4 count \\>100 cells\u002FmL\n\nExclusion Criteria:\n\n1. Known\u002Fsuspected resistance to BDQ, PMD, LZD, or QBS\n2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months\n3. Severe extrapulmonary TB\n4. Abnormal laboratory values: ALT\u002FAST \\>2.5×ULN, Total bilirubin \\>1.5×ULN, eGFR \\\u003C60 mL\u002Fmin\u002F1.73m², Hemoglobin \\\u003C8 g\u002FdL, Platelets \\\u003C100,000 cells\u002Fmm³, WBC \\\u003C2.0×10⁹\u002FL, ANC \\\u003C1000 cells\u002FμL, and HbA1c \\>9.0%\n5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment\n6. Co-enrollment in other therapeutic trials\n7. QTcF \\>450 msec (males) or \\>470 msec (females)\n8. Clinically significant cardiovascular disorders\n9. Bleeding disorders\n10. Conditions interfering with X-ray or sputum assessment\n11. Drug allergies\u002Fhypersensitivity to study medications\n12. Pregnancy or breastfeeding\n13. Positive drug screen (case-by-case assessment for some substances)\n14. Serious mental disorders\n15. Karnofsky score \\\u003C60\n16. BMI \\\u003C16.0 kg\u002Fm²\n17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)\n18. Pulmonary conditions other than TB (silicosis, fibrosis)\n19. Active SARS-CoV-2 infection\n20. Use of prohibited medications\n21. Blood\u002Fplasma donation within 30 days\n22. Current use of herbal remedies or traditional medicines","14 Years",{"count":82,"type":21},532,[84],"PHASE3","This study aims to assess quabodepistat-based treatment regimens for RR\u002FMDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.",[27],[27,88,89,90,91,92,93,94,95,96],"Quabodepistat","Bedaquiline","Pretomanid","Linezolid","Moxifloxacin","Fluoroquinolone-sensitive TB","Fluoroquinolone-resistant TB","Drug-resistant TB","Shortened TB treatment","2026-05-04",{"date":99,"type":32},"2026-05-06",{"date":101,"type":32},"2025-10-16",{"date":103,"type":21},"2028-09-29",{"name":105,"class":106},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",35,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":139},"100628869","phase-2-aiph-tb-ai-optimised-pyrazinamide-hydroxychloroquine-vs-standard-ripe-for-drug-sensitive-pulmonary-tuberculosis---a-phase-ii-rct-100628869","NCT07467252","AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT","A Phase II, Open-Label, Randomised, Parallel-Group, Active-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of AI-Optimised Pyrazinamide 1,500 mg \u002F Hydroxychloroquine 200 mg Twice Daily (AIPH-TB Protocol) Versus Standard Four-Drug RIPE Regimen in Adults With Newly Diagnosed Drug-Sensitive Pulmonary Tuberculosis","AIPH-TB-RCT-P2","Inclusion Criteria:\n\n* Confirmed diagnosis of drug-sensitive pulmonary tuberculosis (bacteriologically confirmed by positive sputum smear microscopy or GeneXpert MTB\u002FRIF)\n* Age 18 to 65 years\n* Naive to anti-tuberculosis treatment (no previous TB treatment or less than 1 month of TB treatment in the past)\n* Willing to provide written informed consent\n* Able to comply with study visits and procedures\n* HIV-negative or HIV-positive with CD4 count ≥200 cells\u002Fmm³ on stable antiretroviral therapy\n\nExclusion Criteria:\n\n* Drug-resistant tuberculosis (confirmed resistance to Rifampicin or Isoniazid)\n* Severe hepatic impairment (Child-Pugh Class C) or ALT\u002FAST \\>3 times upper limit of normal\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Known hypersensitivity to Pyrazinamide, Hydroxychloroquine, or any RIPE drugs\n* Pregnancy or breastfeeding\n* Retinal disease or known contraindications to Hydroxychloroquine\n* Concomitant use of medications with significant interactions with study drugs\n* Extrapulmonary tuberculosis as the primary site\n* Currently enrolled in another clinical trial","65 Years",{"count":118,"type":21},200,[24],"Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of patients. Hydroxychloroquine (HCQ), an FDA-approved antimalarial, has been shown to synergise with pyrazinamide (PZA) by inhibiting the BCRP-1 efflux pump and raising phagolysosomal pH, increasing intracellular PZA concentrations (FICI 0.38 in vitro). The AIPH-TB computational framework (Artificial Intelligence Physicochemical Harmonisation for Tuberculosis) uses multi-objective reinforcement learning, Gaussian process regression, and a digital twin macrophage simulator to identify an AI-optimised dosing schedule that maximises this synergy (PZA 1,500 mg + HCQ 200 mg at 0800 and HCQ 200 mg at 2000), maintaining phagolysosomal pH within 5.2-5.8 for 18 of 24 hours. The computational model predicts FICI 0.28 (strongly synergistic), 9.4-fold increase in intracellular PZA concentration, 99.5% cure rate, and \\\u003C1.5% hepatotoxicity. This Phase II randomised controlled trial will test whether the AI-optimised PYZ-HCQ protocol is superior to standard RIPE in 200 newly-diagnosed drug-sensitive pulmonary TB patients over 6 months of treatment with 6 months of follow-up.",[27],[123,124,125,126,127,128],"Tuberculosis","Pyrazinamide","Hydroxychloroquine","Artificial Intelligence","Drug-Sensitive TB","AIPH-TB","2026-03-09",{"date":131,"type":32},"2026-03-12",{"date":133,"type":21},"2026-09",{"date":135,"type":21},"2028-06",{"name":137,"class":138},"Ministry of Health, Saudi Arabia","OTHER_GOV",1,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100585681","phase-3-a-pan-usr-tb-multi-center-trial-100585681","NCT06905522","A PAN-USR TB Multi-Center Trial","A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial","Inclusion criteria:\n\n1. Age range from 18 to 65 years old, regardless of gender;\n2. Clinical symptoms and\u002For pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;\n3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not; Recommend using respiratory specimens for GeneXpert MTB\u002FRIF testing;\n4. Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;\n5. Willing to undergo HIV testing;\n6. Willing to preserve samples including DNA;\n7. For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female subjects without fertility must have records of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include condoms, intrauterine devices, cervical caps with spermicides, and diaphragm with spermicides.\n\nExclusion criteria:\n\n1. Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);\n2. Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \\[including moxifloxacin, sitagliptin\\], pyrazinamide);\n3. Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \\[including moxifloxacin, sitagliptin\\], pyrazinamide). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB\u002FXDR, dissolution curve method, phenotypic drug sensitivity, etc.);\n4. Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy\u002Fbronchial tuberculosis\u002Fmediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);\n5. Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;\n6. Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;\n7. Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;\n8. Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol;\n9. Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;\n10. HIV positive;\n11. Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;\n12. Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g\u002FL; (4) Platelet count ≤ 50 × 10\\^9\u002FL; (5) Blood potassium levels are ≥ 5.5 mmol\u002FL or ≤ 3.5 mmol\u002FL;\n13. ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;\n14. Women who are pregnant or breastfeeding;\n15. Weight \\\u003C30 kg, or ≥90 kg;\n16. The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;\n17. Other conditions deemed unsuitable for participation in the study by the research doctors.",{"count":148,"type":21},610,[84],"Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases. PAN-TB is an innovative concept in TB treatment, aiming to develop a universal regimen effective for all forms of active TB, including both drug-susceptible and drug-resistant strains. The primary goal of the PAN-TB regimen is to simplify the treatment process, reduce costs, and improve treatment success rates. The ideal Target Regimen Profile (TRP) for PAN-TB includes superior efficacy compared to standard treatment for non-drug-resistant TB, a reduced treatment duration from the current 4-6 months to 2-3 months, and improved safety and tolerability. This project aims to explore a new ultra-short-course treatment regimen for both drug-sensitive (DS-TB) and drug-resistant TB (MDR\u002FRR-TB), which aligns with the latest trends in TB treatment both domestically and internationally. The regimen also has significant practical implications for enhancing treatment efficacy and reducing patient burden. Furthermore, the study will explore the identification of new biomarkers closely linked to treatment outcomes over the course of full-cycle therapy.",[27],"2025-11-27",{"date":154,"type":32},"2025-12-01",{"date":156,"type":32},"2025-06-18",{"date":158,"type":21},"2029-12",{"name":160,"class":70},"Shenzhen Third People's Hospital",3,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":161},"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":171,"type":21},120,[84],"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.",[175,27,123,176],"Rifampicin Resistant Tuberculosis","Drug-resistant Tuberculosis",[178,179,180,56],"drug-resistant tuberculosis","all-oral regimen","9 month regimen","2025-11-26",{"date":183,"type":32},"2025-12-08",{"date":154,"type":21},{"date":186,"type":21},"2028-08-31",{"name":188,"class":70},"Beijing Chest Hospital",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100501295","phase-2-panacea---step2c--01-100501295","NCT05807399","PanACEA - STEP2C -01","A Multiple-arm, Multiple-stage (MAMS), Phase 2B\u002FC, Open-label, Randomized, Controlled Platform Trial to Evaluate Experimental Arms Including Optimised Use of Existing and Introduction of Novel Anti-tuberculosis Drugs, in Adults With Newly Diagnosed, Drug-sensitive, Smear-positive Pulmonary Tuberculosis","Inclusion Criteria:\n\n1. Provide written, informed consent prior to all trial-related procedures including HIV testing.\n2. Male or female, aged between 18 and 65 years, inclusive.\n3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.\n4. Newly diagnosed, previously untreated, drug susceptible pulmonary TB: presence of MTB complex and rapid molecular tests result confirming susceptibility to RIF and INH such as GeneXpert and\u002For HAIN MTBDR plus. Participants who had a previous history of TB may be enrolled in this trial, if they:\n\n   * had a good treatment response in the opinion of the investigator; i.e. TB symptoms improved sufficiently or resolved suggesting a cure of the past episode; AND\n   * no persistent microbiological positivity is seen (in case microbiological results are available); AND - their treatment course was completed AND\n   * the last dose of treatment was more than 3 months ago.\n5. A chest X-ray (no older than 2 weeks) which shows abnormalities that, in the opinion of the Investigator, are consistent with TB.\n6. Sputum positive on microscopy from concentrated sputum for acid-fast bacilli (at least 1+ on the IUATLD\u002FWHO scale) AND\u002FOR positive GeneXpert MTB\u002FRIF Ultra® semi-quantitative result \"medium\" or \"high\" on at least one sputum sample.\n7. The participant understands the interaction between the study drugs and certain foods and is willing to forgo the consumption of those foods for the period of study medication.\n8. The participant is not of child-bearing potential or is willing to use effective methods of contraception when engaging in heterosexual intercourse, as defined below:\n\n   1. Non-childbearing potential:\n\n   i. Female participant\u002Fsexual partner of male participant: Bilateral oophorectomy, and\u002For hysterectomy or bilateral tubal ligation more than 12 months ago and\u002For has been postmenopausal with a history of no menses for at least 12 consecutive months and confirmed by a FSH test.\n\n   ii. Male participant\u002Fsexual partner of female participant: Vasectomised or has had a bilateral orchidectomy minimally three months prior to screening iii. Male participants having a pregnant female partner or a male sexual partner: At least one barrier method has to be used in this case.\n\n   b. Effective contraception methods: i. Female participants: Two methods, including methods that the participant's sexual partner(s) use. At least one must be a barrier method. Contraception must be practised for at least until 12 weeks after the last dose of experimental treatment. For stage 3, female participants of child-bearing potential must have used contraception if any sexual intercourse has occurred after last menses or within the last 3 weeks (whichever is later) before participation, and agree to use non-user dependent contraception: depo-provera injection\\* or an intrauterine device additional to one barrier method.\n\n   \\*Including a back-up method of contraception for at least 7 days to prevent unintended pregnancy if injection has been administered within the first 5 days of their menstrual cycle. Otherwise, a back-up barrier method of contraception is required for one month to prevent unintended pregnancy.\n\n   ii. Male participants: Two methods, including methods that the participant's female sexual partner(s) use. At least one must be a barrier method. Effective contraception must be ensured for at least 12 weeks after the last dose of experimental treatment.\n\n   Exclusion Criteria:\n\n\u003C!-- -->\n\n1. Circumstances that raise doubt about free, unconstrained consent to study participation (e.g., person in detention or person with mental disability)\n2. Poor general condition where delay in treatment cannot be tolerated or death within four months is likely.\n3. Circumstances (in the opinion of the investigator) that raise doubt about ability to complete the follow-up during the study period.\n4. The participant is pregnant or breast-feeding or planning to become pregnant in the study period.\n5. The participant is infected with HIV with a CD4 count \\\u003C220 cells\u002Fmm3. If \\>220 cells\u002Fmm3, participants will be included only if any of the following is applicable:\n\n   • The participant is antiretroviral (ARV) naïve and able to postpone commencing HIV treatment for 2 months after the trial has started and then restrict regimens to those mentioned in section on ARVs or\n\n   • The participant is ARV experienced (has been on ARV´s a minimum of 5 months), AND: ARV treatment is compliant to, or can be modified as described in the section on Antiretroviral Therapy\n6. The participant has a known intolerance to any of the study drugs or concomitant disorders or conditions for which study drugs or standard TB treatment are contraindicated.\n7. The participant has a history of, or current evidence of clinically relevant cardiovascular metabolic, gastrointestinal, neurological, hepato-biliary, renal, psychiatric or endocrine diseases, malignancy, or any other condition that will influence treatment response, study adherence or survival in the judgement of the investigator, especially:\n\n   a. Neuropathy, or significant psychiatric disorder like depression or schizophrenia; especially if treatment for those has ever been required or is anticipated to be required b. Evidence of clinically significant extra-pulmonary TB (e.g. miliary TB, TB meningitis, but not limited lymph node involvement) c. Serious lung conditions other than TB, or significant respiratory impairment in the discretion of the investigator d. Uncontrolled diabetes mellitus or diabetes mellitus receiving\u002Frequiring treatment with metformin or sulfonylureas e. Cardiovascular disease such as myocardial infarction, heart failure, coronary heart disease, arrhythmia, tachyarrhythmia, or pulmonary hypertension f. Uncontrolled arterial hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure of ≥95 mmHg on two occasions during screening. An attempt at antihypertensive treatment during the screening period is permitted).\n\n   g. Long QT syndrome or family history of long QT syndrome or family history of sudden death of unknown or cardiac-related cause h. Alcohol, regular opiate, or other drug abuse that is sufficient to significantly compromise the safety or cooperation of the participant, that includes substances prohibited by the protocol or has led to significant organ damage at the discretion of the investigator; AND\u002FOR any abuse of methamphetamine.\n\n   i. History of optic neuropathy j. Vitiligo\n8. Any of the following laboratory findings at screening:\n\n   a. Serum amino aspartate transferase (AST) and\u002For alanine aminotransferase (ALT) \\>3x the upper limit of normal (ULN), b. Serum alkaline phosphatase or y-glutamyl transferase \\> 2.5x the ULN, c. Serum total bilirubin level \\>1.5x the ULN d. Estimated creatinine clearance -eCrCl (using the CKD-EPI 2021 creatinine formula):\n\n   \\- Stage 1: Lower than 30 ml\u002Fmin)\n\n   \\- Stage 2: Lower than 30ml\u002Fmin or lower than 60 ml\u002Fmin in participants living with HIV\n\n   \\- Stage 3: Lower than 80ml\u002Fmin e. Proteins in urine dipstick \\>=2+ f. Haemoglobin level \\\u003C7.0 g\u002Fdl g. Platelet count \\\u003C50,000\u002Fmm3, h. Serum potassium below 3 mmol\u002Fl, persisting after correction.\n9. ECG findings in the screening ECG: (one or more):\n\n   1. QTcF of \\>450 milliseconds\n   2. Atrioventricular (AV) block with PR interval \\> 200 milliseconds\n   3. QRS complex \\> 120 milliseconds\n   4. Any other changes in the ECG that are clinically relevant as per discretion of the investigator\n10. Restricted medication:\n\n    1. Treatment with any other investigational drug within 2 month prior to enrolment or enrolment into other clinical (intervention) trials during participation.\n    2. Previous anti-TB treatment with drugs active against MTB within the last 3 months prior to screening.\n    3. Unable or unwilling to abide by the requirements regarding restricted medication or have taken restricted medication. Restricted medication includes the following drug classes, with relevant timing of intake, and possible exceptions. Exceptions may be permissible after discussion with the sponsor medical expert.",{"count":197,"type":21},390,[24],"This is a phase 2B\u002FC, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis.\n\nIn stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1.\n\nIn stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4 in a ratio of 1:1:1:2. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.\n\nIn stage 3, participants will be allocated in parallel to control arm treatment (now designated arm 7) or the experimental arms 5 and 6, favouring arm 5, 2:1:1 over arms 6 and control. This stage will start after completion of recruitment in the stages 1 and 2. Enrolment of participants into arm 5 will proceed following review of data from the ENABLE\u002FUNITE-03 (NCT06748937), non-clinical safety data and after endorsement by the DSMB. Thus, arm 5 recruitment might start after arms 6 and 7, which may require an increase in the control arm sample size to ensure controls are recruited concomitantly.",[27,201],"Other Specified Pulmonary Tuberculosis",[203,123,204,205,206,207,92,208,209],"Tuberculosis, Pulmonary","Antitubercular Agents","Safety","Tolerability","Pharmacokinetics (PK)","BTZ-043","Rifampicin","2025-10-01",{"date":212,"type":32},"2025-10-07",{"date":214,"type":32},"2023-04-14",{"date":216,"type":21},"2027-12-30",{"name":218,"class":70},"Michael Hoelscher",10,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":241},"100524891","phase-2-platform-assessing-regimens-and-durations-in-a-global-multisite-consortium-for-tb-100524891","NCT06114628","Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB","A Seamless Phase 2B\u002FC Platform Trial to Evaluate Multiple Regimens and Durations of Treatment in Pulmonary Tuberculosis","PARADIGM4TB","Inclusion Criteria:\n\n1. Age 18 years or above at screening (or above age of legal consent at screening, if this is higher than 18 years in the jurisdiction in which the study is taking place)\n2. Clinical evidence of active TB disease, meeting either or both of the following criteria:\n\n   * Symptoms consistent with pulmonary TB at screening AND\u002FOR\n   * Imaging findings consistent with active pulmonary TB on chest X-ray performed at screening or within 7 days prior to screening\n3. At least one sputum specimen produced at screening tested on Xpert MTB\u002FRIF Ultra that has:\n\n   * a semi-quantitative result of 'medium' or 'high' AND\n   * does not show rifampicin resistance\n4. Body weight within the range of 30 to 100kg and body mass index within the range of 15 to 40kg\u002Fm2\n5. Willing to comply with study visits, all study procedures and treatment observation\n6. Resident at a fixed address that is readily accessible for visiting, within feasible travelling distance to the site and likely to remain resident there for the duration of trial follow-up\n7. Has provided written informed consent\n\nExclusion Criteria:\n\n1. Taken more than 1 daily dose of medication with anti-tuberculous activity during the 14 days prior to randomisation (isoniazid, rifampicin, pyrazinamide, ethambutol; linezolid, moxifloxacin, levofloxacin or amikacin) (for Phase 2b and Phase 2c)\n2. Known isoniazid resistance (at sites where national isoniazid monoresistance is greater than 10% rapid testing at screening is mandated; at other sites rapid testing at screening is optional)\n3. Known or suspected extra-thoracic TB, miliary TB or disseminated TB (in the judgement of the investigator; note uncomplicated pleural effusion occupying \\\u003C50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions)\n4. Severe clinical pulmonary TB e.g. respiratory failure or complications likely to require hospital admission in the opinion of the investigator\n5. Poor general condition (Karnofsky score ≤50) OR where any delay in treatment cannot be tolerated in the opinion of the investigator\n6. Active malignancy requiring systemic therapy, radiotherapy or palliative therapy\n7. History of myocardial infarction, coronary heart disease or congestive cardiac failure; long QT syndrome or clinically significant arrhythmias; pulmonary hypertension; any known congenital cardiac problems; family history of long QT syndrome or sudden death from unknown or cardiac related cause; uncontrolled arterial hypertension (not excluded if this is corrected prior to randomisation)\n8. Vitiligo\n9. History of seizure(s)\n10. Current tendinitis (any cause) or history of tendinopathy associated with fluoroquinolone use\n11. History of vascular aneurysm\n12. Symptomatic peripheral neuropathy causing greater than minimal interference with usual social and functional activities\n13. Current alcohol or illicit drug use sufficient to compromise the safety of the participant or research staff or compromise adherence to study procedures, in the opinion of the investigator\n14. Any current or recent use of amphetamines or methamphetamines, either reported or evident on toxicity screen, if performed\n15. Any other medically or socially significant condition (e.g. psychiatric illness, chronic diarrhoeal disease, metabolic condition, other cardiovascular disease not listed under criterion 7), that would, in the opinion of the investigator, compromise the participant's safety or outcome in the trial; or lead to poor compliance with study visits and protocol requirements; or compromise the interpretation of trial safety and efficacy endpoints\n16. Women who are currently pregnant or breast-feeding\n17. Women of childbearing potential unwilling or unable to use appropriate effective contraception during the study intervention period and for at least 14 days after the last dose of study intervention; and unwilling to commit to refrain from donating eggs (ova, oocytes) for the purpose of reproduction during this period; definitions of childbearing potential and appropriate effective contraception given below\\*\\*\n18. Men who are unwilling to use a condom during the study period and for at least 90 days after the last dose of study drug during any activity that allows for the passage of ejaculate to another person; and are unwilling to commit to refrain from donating fresh unwashed semen\n19. Known allergy to one or more of the study drugs\n20. Taking a concomitant medication that has a known or predicted interaction with any of the study drugs to which the participant might be randomised. The participant need not be excluded if:\n\n    1. the concomitant medication can be stopped or replaced with an alternative non-interacting medication, if needed AND\n    2. the investigator judges there to be no residual clinical risk to the participant after stopping the concomitant medication (taking into account the washout period of 5x the half-life of the concomitant medication and the duration of the effect of the interaction on levels of study medication)\n21. Taking a concomitant medication that is known to prolong the QTc interval. The participant need not be excluded if the concomitant medication can be stopped or replaced with an alternative medication, if needed, and the duration of the QTc prolongation is expected to resolve prior to dosing of study medication (taking into account the washout period of 5x the half-life of the concomitant medication)\n22. Treatment with any immunosuppressive drugs within the 2 weeks prior to screening (taking systemic corticosteroids for less than 5 consecutive days and stopped at or prior to screening are not an exclusion; topical or inhaled steroids that are taken at a dose below the threshold considered to have systemic immunosuppressive effects are not excluded)\n23. Participation in other clinical intervention trial with an investigational agent within 8 weeks prior to the first dosing day in this trial\n24. 12-lead ECGs at screening or at baseline shows QTcF \\>450ms (men) or \\>460ms (women) calculated by Fridericia's formula; and\u002For any other clinically significant abnormality such as arrhythmia or ischaemia\n25. Any of the following laboratory parameters at screening:\n\n    1. Haemoglobin \\\u003C 9g\u002Fdl\n    2. Platelet count \\\u003C 50 x 109 cells\u002FL\n    3. Absolute neutrophil count \\\u003C1000 cells\u002FμL\n    4. Creatinine clearance of \\\u003C75ml\u002Fmin, calculated using Cockcroft-Gault equation\\*\n    5. ALT or AST \\> 3 times the upper limit of normal\n    6. Total bilirubin \\> 1.5 times upper limit of normal\n    7. Serum potassium \\\u003C3.5 mmol\u002FL (not excluded if corrected to above this level)\n    8. Serum magnesium \\\u003C 0.70mmol\u002FL (not excluded if corrected to above this level)\n    9. Serum calcium (corrected for albumin level) \\\u003C 2.10 mmol\u002FL (not excluded if corrected to above this level)\n26. Hepatitis B surface antigen positive (known, or on a test performed at screening)\n27. HIV antibody positive (known, or on test performed at screening)\\*\n28. Known Hepatitis C virus infection (unless also known to have negative PCR test)\\*",{"count":229,"type":21},2500,[24],"The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB). The standard treatment for TB takes 24 weeks and uses four drugs. The consortium want to find new treatments that are faster but just as safe and effective.\n\nIn the trial, two new drugs will be used, BTZ-043 and GSK3036656, along with the drugs that are already used to treat TB in a variety of combinations (11 different combinations initially). These new drugs have worked well in tests with animals and have reduced the amount of TB bacteria in people's sputum\u002Fphlegm when used alone for two weeks. These new drugs will be used in combination with other TB drugs for a longer time (up to 16 weeks) in people with TB. The UNITE4TB consortium want to see if they work well and are safe.\n\nThis trial will take place at sites across the world and will involve people with TB of the lungs that would usually respond well to the standard treatment. But the new treatments being tested might also work for people with drug resistant TB, that's harder to treat.\n\nThe trial has two parts. In the first part, different combinations of drugs will be tried on up to 700 people for 16 weeks. These combinations will be compared to the standard 24-week treatment to see which ones work the best and are safe.\n\nIn the second part, the best combinations from the first part will be taken to try to find out what the best length of time is to give the treatment for. These combinations will be tried on up to 1800 people giving them either 8, 10, 12, 14 or 16 weeks treatment. The investigators will follow these people for a total of 72 weeks to make sure the treatment is working.\n\nThe UNITE4TB consortium hope that this trial will find new treatments that are fast, safe, and effective for both regular TB and resistant TB. If it works, it can then be tested again in a bigger trial to be sure.",[27],"2025-09-30",{"date":235,"type":32},"2025-10-06",{"date":237,"type":32},"2024-01-09",{"date":36,"type":21},{"name":240,"class":70},"University College, London",11,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":250,"sex":17,"minAge":169,"maxAge":116,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100531447","phase-2-atorvastatin-in-pulmonary-tuberculosis-100531447","NCT06199921","ATORvastatin in Pulmonary TUBerculosis","Atorvastatin-containing Treatment Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled phase2C\u002F3 Clinical Trial","ATORTUB","Inclusion Criteria:\n\nIndividuals must meet all the following inclusion criteria in order to participate in this study:\n\nA. Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB\u002FRIF testing, with semiquantitative result of 'medium' or 'high' and rifampicin resistance not detected.\n\nB. Treatment naive\n\nC. Age twelve years or older\n\nD. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.\n\nE. Documented HIV infection status.\n\nF. Documented blood sugar level\u002F Diabetes\n\nG. For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells\u002Fmm3 based on testing performed at or within 30 days prior to screening.\n\nH. Laboratory parameters done at or within 14 days prior to screening:\n\n* Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal\n* Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal\n* Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal\n* Serum or plasma potassium level greater than or equal to 3.5 meq\u002FL\n* Hemoglobin level of 7.0 g\u002FdL or greater\n* Platelet count of 100,000\u002Fmm3 or greater\n\nI. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening\n\nJ. Written informed consent\n\nExclusion Criteria:\n\nIndividuals with any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded.\n\nA. Pregnant or breast-feeding\n\nB. Unable to take oral medications\n\nC. Those already on treatment for tuberculosis\n\nD. Weight less than 40.0 kg\n\nE. Known allergy or intolerance to any of the study medications\n\nF. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide,or ethambutol,\n\nG. .Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.\n\nH. Known or family history of bleeding disorders. I. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.\n\nJ. Myositis and or Creatinine phosphokinase three times upper limit of normal K. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.\n\nCriteria for Exclusion after Enrollment ('Late Exclusion')\n\nMicrobiological confirmation of drug-susceptible tuberculosis is not expected always to be available at the time of enrollment. Enrolled individuals who are subsequently determined to meet either of the following criteria will be classified as 'late exclusions' and study treatment will be discontinued:\n\nA. Screening, baseline, and Week 2 study visit sputum cultures all fail to grow M. tuberculosis.\n\nB. M. tuberculosis cultured or detected through molecular assays (Cepheid Xpert MTB\u002FRIF or Hain MTBDRplus assays) from sputum obtained around the time of study entry is determined to be resistant to one or more of isoniazid, rifampin, or fluoroquinolones.",true,{"count":252,"type":21},440,[24],"Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majority of TB cases and TB deaths are in developing countries. Nigeria has the highest TB burden in Africa with a high number of undetected TB cases as well. The spread of HIV has fueled the TB epidemic, and TB is the leading cause of death among patients infected with HIV and has assumed the lead position as the number one infectious disease cause of death globally. Even though the COVID-19 was associated with a huge mortality, TB contributed significantly to death and one of the single predictors of death among COVID-19 infected individuals. TB predominantly affects young adults in their most productive years of life and has substantial impact on economic development.\n\nEmerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatment regimen. The ATORTUB group recently completed Phase II A and Phase IIB studies to assess the safety, tolerability and efficacy of atorvastatin when administered with the current standard of care. The investigators demonstrated that atorvastatin is well tolerated, save, and has beneficial microbiological and radiological impacts in tuberculosis, thus, warrants further studies.\n\nThis phase IIC trial sets out to evaluate the safety and efficacy of different doses of atorvastatin containing regimen, determine rate of decline of viable sputum bacilli, the time to stable sputum conversion, improvement in chest ray severity scores and lung function parameters post randomization in the different treatment arms. The phase II C is a Selection Trial with Extended follow-up STEP and has been devised as a pilot phase III where patients are studied for longer period (12months post randomization) than the usual phase IIB. Thus, providing additional data that will justify a successful phase III trial.",[27,123,256],"Koch's Disease",[258,259,260,261,262],"Atorvastatin","Anti-tuberculosis","HMG-COA Inhibitor","Statins","Anti TB drugs","2025-09-21",{"date":265,"type":32},"2025-09-25",{"date":267,"type":32},"2024-01-03",{"date":269,"type":21},"2026-09-30",{"name":271,"class":70},"Obafemi Awolowo University Teaching Hospital",8,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":116,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":4},"100598802","phase-3-ultra-short-regimen-for-elderly-ds-tb-100598802","NCT07076225","Ultra-Short Regimen for Elderly DS-TB","A Ultrashort Regimen for Drug-susceptible Pulmonary Tuberculosis in Elderly Patients: A Multicenter Randomized Controlled Trial","Elderly-USR","Inclusion criteria:\n\n1. Aged 65 years or older, regardless of gender\n2. Clinical symptoms and\u002For pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;\n3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, and susceptible to rifampicin; Recommend using respiratory specimens for GeneXpert MTB\u002FRIF testing;\n4. Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;\n5. Willing to undergo HIV testing;\n6. Willing to preserve samples including DNA;\n\nExclusion criteria:\n\n1. Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);\n2. Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc);\n3. Resistance to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB\u002FXDR, dissolution curve method, phenotypic drug sensitivity, etc.);\n4. Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy\u002Fbronchial tuberculosis\u002Fmediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);\n5. Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;\n6. Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;\n7. Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;\n8. Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol;\n9. Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;\n10. HIV positive;\n11. Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;\n12. Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g\u002FL; (4) Platelet count ≤ 50 × 10\\^9\u002FL; (5) Blood potassium levels are ≥ 5.5 mmol\u002FL or ≤ 3.5 mmol\u002FL;\n13. ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;\n14. Weight \\\u003C30 kg, or ≥90 kg;\n15. The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;\n16. Other conditions deemed unsuitable for participation in the study by the research doctors.",{"count":282,"type":21},300,[84],"Tuberculosis (TB) remains one of the leading global public health concerns and is among the top ten causes of death from a single infectious agent. China ranks third worldwide in total TB burden, with a substantial proportion of cases classified as drug-susceptible TB (DS-TB). Despite the availability of effective standard treatment regimens, the current 6-month therapy duration poses challenges in terms of patient adherence, resource allocation, and overall treatment success.\n\nIn recent years, ultrashort-course regimens for DS-TB have been proposed and evaluated in clinical studies, showing promising results in improving adherence, reducing treatment duration, and maintaining or even enhancing treatment efficacy. However, these regimens have primarily been studied in younger populations, with limited data available for elderly patients. Older adults often present with age-related physiological changes, multiple comorbidities, and an increased risk of adverse drug reactions, which may affect both the efficacy and safety of treatment.\n\nTherefore, this study aims to assess the therapeutic effectiveness and safety profile of a novel ultrashort-course regimen for drug-susceptible pulmonary TB specifically in patients aged 65 years and older.",[27],"2025-07-18",{"date":288,"type":32},"2025-07-22",{"date":290,"type":21},"2025-07-25",{"date":292,"type":21},"2030-07-31",{"name":160,"class":70},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":302,"conditions":303,"keywords":312,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":139},"100587017","perioperative-risk-factors-related-to-the-prognosis-of-lung-transplantation-a-retrospective-study-100587017","NCT06922916","Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study","Inclusion Criteria:\n\n* Age \\>18 years at time of transplantation\n* Received single or bilateral lung transplantation\n\nExclusion Criteria:\n\n* Re-transplantation\n* Multi-organ transplantation\n* Autotransplantation\n* Incomplete medical records: Recipients with \\>20% missing essential data elements in any of these categories:Preoperative baseline characteristics； Intraoperative parameters；Postoperative outcome measures",{"count":301,"type":21},250,"This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. It gathers patient data from hospital and Mediston systems, with main focus on in-hospital complications and secondary focus on ICU stay, post-op hospitalization, mortality, and intubation time. The research aims to deepen understanding of anesthetic management's role in lung transplant outcomes and guide improvements in perioperative anesthesia protocols.",[304,305,306,307,308,309,27,310,311],"COPD","Interstitial Pneumonia","Bronchiectasis","Respiratory Failure","Idiopathic Pulmonary Fibrosis (IPF)","Silicosis","Pulmonary Hypertension","Pulmonary Heart Disease",[313,314,315,316,317],"lung transplantatipn","Perioperative-related risks","Mortality","In-hospital complications","Prognosis","2025-04-21",{"date":320,"type":32},"2025-04-22",{"date":320,"type":21},{"date":323,"type":21},"2026-04-30",{"name":325,"class":70},"Zhejiang University",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":139},"100382503","phase-3-novel-triple-dose-tuberculosis-retreatment-regimen-100382503","NCT04260477","Novel Triple-dose Tuberculosis Retreatment Regimen","Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger","Tri-Do-Re","Inclusion Criteria:\n\n* All newly registered patients with smear-positive recurrent pulmonary TB\n* Adults as well as children (no age limit)\n* Able and willing to provide written informed consent\n* Added for stage 2: lives within 5 km of a health facility with a medical doctor\n\nExclusion Criteria:\n\n* All patients with TB initially resistant to rifampicin on Xpert MTB\u002FRIF testing\n* Patients transferred to a health facility not supported by the Damien Foundation\n* Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period\n* Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening\n* Pregnant or breastfeeding woman\n* HIV co-infected patients requiring treatment with a protease inhibitor",{"count":335,"type":21},370,[84],"To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).",[339,27,123,340],"Multidrug-resistant Tuberculosis","Resistance to Tuberculostatic Drugs",[342,123,343,344,345,346],"rifampicin-susceptible-TB","first-line","TB relapse","TB treatment failure","high dose retreatment","2025-04-10",{"date":349,"type":32},"2025-04-13",{"date":351,"type":32},"2021-03-01",{"date":353,"type":21},"2025-09",{"name":355,"class":70},"Institute of Tropical Medicine, Belgium",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":250,"sex":17,"minAge":18,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":366,"conditions":367,"keywords":381,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":139},"100556693","identification-of-multiple-pulmonary-diseases-using-volatile-organic-compounds-biomarkers-in-human-exhaled-breath-100556693","NCT06528418","Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath","Exploration and Study on the Identification of Various Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath","Inclusion Criteria:\n\n* Males or females, age must be 18 years old or above.\n* Patients must meet the CT imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of CT image data.\n* Patients must have a clear clinical diagnosis.\n* All participants must sign a written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Individuals with a history of cancer other than lung disease.\n* Individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants.\n* Individuals with other severe organic diseases or mental illnesses.\n* Individuals with metabolic diseases such as diabetes, hyperlipidemia, etc.\n* Any other condition that researchers deem unsuitable for participation in this clinical trial.","100 Years",{"count":365,"type":21},10000,"The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. The primary objectives it strives to accomplish are:\n\n1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose several common pulmonary diseases.\n2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.",[368,369,304,370,371,372,373,27,374,375,376,377,378,306,379,380],"Lung Cancer","Lung Infection","Bronchitis","Pulmonary Fibrosis","Pulmonary Embolism","Pulmonary Arterial Hypertension","Pulmonary Abscess","Emphysema","Lung Injury","Cystic Fibrosis of the Lung","Bronchial Asthma","Interstitial Lung Disease","Preserved Ratio Impaired Spirometry",[382,383,384,385,386],"Pulmonary Disease","Volatile Organic Compounds","Human Exhaled Breath","micro Gas Chromatography-photoionisation","detector (μGC-PID) system","2025-03-23",{"date":389,"type":32},"2025-03-26",{"date":391,"type":32},"2024-06-30",{"date":393,"type":21},"2027-06-30",{"name":395,"class":106},"ChromX Health",{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":403,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":272},"100572023","phase-3-short-course-regimen-in-low-risk-active-tuberculosis--a-multicenter-randomized-active-controlled-trial-100572023","NCT06727864","Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial","Safety and Efficacy of Four-month Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Newly diagnosed pulmonary tuberculosis patients combined with any of the following diagnostic conditions:\n\n  * at least one set of sputum specimens is positive for Mycobacterium tuberculosis culture or TB PCR test; or\n  * pathological and histological findings of typical tuberculosis manifestations;\n  * clinical diagnosis and Physician determines the need for complete anti-tuberculosis treatment\n* Those who have had tuberculosis in the past and have been cured for at least three years can be included\n* Aged over 20 years old\n* Laboratory data at the time of inclusion in the study or within 14 days:\n\n  * Serum or plasma glutamic acid pyruvate transaminase (ALT) value ≦ three times the upper limit of normal\n  * Serum or plasma total bilirubin ≦ 2.5 times the upper limit of normal\n  * Serum or plasma creatinine ≦ twice the upper limit of normal or creatinine clearance greater than 30 mL\u002Fmin\n  * Heme ≧7.0 g\u002FDl\n  * Platelets ≧100,000\u002Fmm3\n* Patient signs consent form\n* Patients who agree to join and cooperate with the county and city health bureau's urban treatment plan to ensure medication compliance.\n\nExclusion Criteria:\n\n* The acid-fast smear of sputum or respiratory specimen is strongly positive (≥ 2+)\n* Chest X-ray or lung computed tomography combined with open lesions\n* Chest X-ray or lung computed tomography shows extensive lesions and the clinician judges that short-term treatment is not suitable\n* Simultaneous combination of intrapulmonary and extrapulmonary tuberculosis\n* People who are unable to take oral medications\n* People who have participated in this research\n* Have used anti-tuberculosis drugs for more than 14 days\n* A history of tuberculosis suspected or diagnosed as central nervous system tuberculosis, bone or joint tuberculosis, miliary tuberculosis or tuberculous pericarditis.\n* Known history of allergy or intolerance to this study drug\n* Patients with HIV infection, organ transplantation, and chronic renal failure\n* Long-term use of immunosuppressive drugs, including steroid use \\>10mg\u002Fday (more than 30 consecutive days in the last three months)\n* Late exclusion: Mycobacterium tuberculosis is known to be resistant to any one or more of the following drugs: rifampin, isoniazid, ethambutol","20 Years","99 Years",{"count":406,"type":21},270,[84],"Tuberculosis remains an important global health problem, and the world is currently not on track to end the TB epidemic by 2030. With the concerted efforts of the government and medical community, the incidence of TB in Taiwan has gradually decreased, however, Taiwan remains an endemic area for TB. The development of efficacious, safe, and shorter treatment regimens could significantly improve treatment completion rate and reduce transmission of TB. The current treatment guidelines for drug-susceptible TB from the World Health Organization (WHO), American Thoracic Society (ATS), United States Center for Diseases Control (U.S. CDC), Infectious Diseases Society of America (IDSA) and European Respiratory Society (ERS) include 2 months of isoniazid, rifampin, pyrazinamide and ethambutol (HREZ), followed by 4 months of isoniazid, rifampin, and ethambutol(HRE). The current treatment regimen requires 6 months of treatment, despite being highly efficacious, requires long duration of treatment. Adherence to treatment is the major barrier which poses a negative impact to TB control, and increased cost to both the patient and the public health system. Developing an efficacious, safe and short treatment regimen can significantly improve TB management and treatment success rates.",[27],[56,411,412,413,414],"short course regimen","safety","sputum conversion","recurrence rate","2025-03-21",{"date":417,"type":32},"2025-03-25",{"date":419,"type":32},"2024-01-01",{"date":421,"type":21},"2028-12-31",{"name":423,"class":70},"Kaohsiung Veterans General Hospital.",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":444},"100552678","phase-4-the-safety-and-efficacy-of-bdlbedaquiline-plus-delamanid-plus-linezolid-regimen-in-subjects-with-pulmonary-infection-of-multi-drug-resistant-tuberculosis-mdr-tb-or-rifampicin-resistant-tuberculosis-rr-tb-100552678","NCT06476210","The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)","Inclusion Criteria\n\n* 1.A patient with multi-drug resistant\u002Frifampicin-resistant pulmonary tuberculosis (MDR\u002FRR-TB) with recent laboratory evidence (culture or molecular testing) within the last two months\n* 2.Age 18 years above\n* 3.No prior use of neither bedaquiline, delamanid, linezolid, or use for less than 4 weeks\n* 4.Positive culture result for mycobacterial at baseline(regardless smear positive or negative). No anti-tuberculosis treatment received within one month.\n* 5.For patients who don't have baseline sputum culture results,positive sputum smear and no effective anti-tuberculosis treatment administered\n* 6\\. No history of respiratory failure or heart failure, and no clinically significant manifestations of arrhythmia, with a QTcF under 450ms\n* 7.Promise to adhere to the treatment and follow-up schedule, complete treatment monitoring, and promptly report adverse reactions to the responsible physician\n* 8.Voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria\n\n* 1.According to DMID, peripheral neuropathy is classified as grade 3 or 4. Alternatively, participants with grade 1 or 2 neuropathy, which the investigator believes may progress\u002Fworsen during the study\n* 2.Elevation of ALT or AST ≥3 times the upper limit of normal, or elevation of total bilirubin and direct bilirubin ≥2 times the upper limit of normal\n* 3.Pregnant women or those who intent to pregnant during treatment\n* 4.Participants who have participated in other drug trials in the past three months\n* 5.Known congenital QT interval prolongation or any disease prolonging the QT interval, or QTc\\>450 ms\n* 6.History of symptomatic arrhythmias or clinically relevant bradycardia\n* 7.Any cardiac disease that could precipitate arrhythmias, such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure with decreased left ventricular ejection fraction\n* 8.History of known, untreated, persistent hypothyroidism\n* 9.Electrolyte disturbances, especially hypokalemia, hypocalcemia, or hypomagnesemia\n* 10.History of allergy or known allergic reactions to any investigational drug or related substances\n* 11.BMI\\\u003C17 kg\u002Fm2\n* 12.Karnofsky performance score under 50, or as determined by the principal investigator, the anticipated survival of the participant is not expected to exceed 6 months\n* 13.Participants expected to require surgical intervention following assessment of their pulmonary disease\n\nWithdrawal Criteria\n\n1. Serious adverse events caused by the intervention\n2. Confirmed QTcF interval ≥ 500ms or clinically significant ventricular arrhythmias\n3. The expert panel deems the continuation of this combination regimen inappropriate\n4. The patient requests withdrawal",{"count":431,"type":21},45,[433],"PHASE4","The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary tuberculosis, in the context of Pretomanid not available in China. It will also learn about the safety of BDL regimen.\n\nThe main questions it aims to answer are:\n\n1. What is the percentage of participants with favorable treatment outcome at the end of treatment?\n2. What are the frequency and degree of AE and SAE associated with BDL regimen?\n\nParticipants will take Bedaquiline +Delamanid+ Linezolid for 6 months, option for 9 months for subjects who remain culture positive at month 4 to 6. Safety and efficacy data will be monitored and collected during treatment. A 12 month follow-up will be conducted after treatment completion.",[27],"2024-06-24",{"date":438,"type":32},"2024-06-26",{"date":440,"type":21},"2024-06",{"date":442,"type":21},"2026-06",{"name":188,"class":70},7,{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":455,"conditions":456,"keywords":457,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":71},"100525892","rehabilitation-of-people-with-post-tuberculosis-lung-disease-100525892","NCT06127641","Rehabilitation of People With Post-tuberculosis Lung Disease","Inclusion Criteria:\n\n* Patients with post-tuberculosis lung disease, clinically stable and able to perform \\>80% of training sessions.\n\nExclusion Criteria:\n\n* Presence of comorbidities not related to PD-PTB.\n* Patients with inability to perform TGlittre.\n* Patients who have cognitive changes that impair their inclusion in the study.\n* Treatment abandonment during the application of the PR protocol.\n* Uncontrolled hypertension or use of psychotropic medications.\n* Any significant limitations due to osteoarthropathy.\n* Having had any orthopedic surgery in the previous year.",{"count":452,"type":21},40,[454],"NA","Tuberculosis (TB) can leave numerous sequelae, where survivors experience a transition from an acute illness to living with a multifaceted chronic illness. Post-TB lung disease (PD-PTB) encompasses lung diseases and pathologies that occur after one or more episodes of TB, which can affect the patient's lung health and cause disabling symptoms that strongly affect their long-term health. In 2020, it was estimated that there were 155 million TB survivors still alive worldwide, with a large proportion of them carrying functional sequelae with profound socioeconomic repercussions. Thus, the aim of this study is to evaluate the effect of pulmonary rehabilitation (PR) on functionality and health-related quality of life (HRQoL) of people with PD-PTB and to build a PD-PTB severity scoring system based on the data. of pre-RP individuals using artificial intelligence technique.",[27],[458,459,460,461,462,463],"Pulmonary tuberculosis","Tuberculosis sequelae","Rehabilitation","ADL-Glittre test","Functionality","Quality of life","2023-11-07",{"date":466,"type":32},"2023-11-13",{"date":468,"type":32},"2023-10-28",{"date":470,"type":21},"2027-12-31",{"name":472,"class":70},"Centro Universitário Augusto Motta"]