[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-susceptible-pulmonary-tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-susceptible-pulmonary-tuberculosis":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,70,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100632727","phase-2-bactericidal-activity-and-safety-of-nicotinamide-in-combination-with-bedaquiline-pretomanid-and-linezolid-in-drug-susceptible-pulmonary-tuberculosis-100632727",false,"NCT07517445","Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis","A Phase 2, Open-label, Randomized Controlled Trial to Assess the Safety, Bactericidal Activity, and Pharmacokinetics of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Adults With Drug-susceptible Pulmonary Tuberculosis","Inclusion Criteria:\n\n* Age 18-65 years at consent\n* Body weight 40-100 kg at screening\n* Written informed consent obtained\n* Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive\n\n  * ≥1+ AFB smear OR positive Xpert semi-quantitative result\n  * Molecular confirmation of M. tuberculosis\n* Chest X-ray consistent with TB (Investigator assessment)\n* Able to spontaneously produce sputum\n* Contraception requirements met\n* Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence\n* Males: contraception or abstinence through 90 days post-dose\n\nExclusion Criteria:\n\n* Prior TB within 3 years, \\>1 prior episode, or anti-TB treatment within 60 days\n* Extrapulmonary TB (except non-significant pleural\u002Flymph node disease)\n* Clinically significant comorbidities or substance abuse impacting safety\u002Fcompliance\n* Pregnant or breastfeeding\n* HIV-positive AND any of the following:\n* Not on ART or on ART \\\u003C3 months\n* CD4 \\\u003C200 cells\u002FµL\n* Viral load \\>200 copies\u002FmL\n* AIDS-defining illness (other than pulmonary TB)\n* Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)\n* Clinically significant ECG abnormality\n* Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)","ALL","18 Years","65 Years",{"count":20,"type":21},165,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.",[27],"Drug Susceptible Pulmonary Tuberculosis",[29,30,31,32,33],"Nicotinamide","bedaquiline","pretomanid","linezolid","drug-susceptible pulmonary tuberculosis","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2026-04-17",{"date":42,"type":21},"2027-06-14",{"name":44,"class":45},"Gates Medical Research Institute","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100633341","phase-2-bactericidal-activity-of-tbd09-in-combination-with-other-drugs-in-pulmonary-tuberculosis-100633341","NCT07525427","Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis","A Phase 2, Open-Label, Multi-Group, Controlled, Randomized Trial of the Safety, Bactericidal Activity, and Pharmacokinetics of TBD09 in Combination With Other Active Agents in Adults With Drug-Sensitive Pulmonary Tuberculosis","Inclusion Criteria:\n\n* Age 18-65 years at consent\n* Body weight 35-100 kg at screening\n* Written informed consent obtained\n* Newly diagnosed rifampicin-sensitive pulmonary TB\n\n  * Molecular confirmation of M. tuberculosis on Xpert MTB\u002FRIF Ultra\n  * ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result\n  * Rifampicin sensitivity on molecular test\n* Chest X-ray consistent with TB (Investigator assessment)\n* Able to spontaneously produce sputum\n* Reproductive requirements met\n* Women of childbearing potential: 2 approved contraceptive methods or abstinence\n* Males: contraception or abstinence through 90 days post-dose\n\nExclusion Criteria:\n\n* Prior anti-TB treatment for the current TB episode within 60 days\n* Prior medication active against Mtb within 3 months\n* Evidence of extra-thoracic TB, per investigator judgement\n* Prior treatment completion for TB within 3 years\n* 2 or more prior episodes of TB\n* Clinically significant history of or current medical condition posing safety risk\n* If HIV positive:\n\n  * Not on ARVs or taking ARVs for \\\u003C3 months prior to screening OR\n  * CD4+ count \\\u003C200cells\u002FuL at screening OR\n  * HIV viral load \\>200 copies \u002FmL at screening OR\n  * AIDS infection or malignancies\n* Meets any of the following laboratory values during screening:\n\n  * AST, ALT, or ALP ≥2.5× ULN\n  * Total bilirubin ≥1.2× ULN\n  * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²\n  * Hemoglobin \\\u003C9.0 g\u002FdL (male) or \\\u003C8.5 g\u002FdL (female)\n  * White blood cell count \\\u003C2,000\u002Fmm³\n  * Absolute neutrophil count \\\u003C800\u002Fmm³\n  * Platelet count ≤100,000\u002Fmm³\n  * Positive hepatitis B surface antigen\n  * Positive hepatitis C antibody\n  * HbA1c ≥8.0%\n* Current or recent systemic immunosuppressive therapy, including corticosteroids\n* Significant drug or alcohol abuse affecting compliance or safety\n* Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment",{"count":54,"type":21},150,[24],"The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.",[27],[59,60,30,31,32,33],"TBD09","oxazolidinone","2026-06-01",{"date":63,"type":38},"2026-06-03",{"date":65,"type":38},"2026-04-14",{"date":67,"type":21},"2026-11-05",{"name":44,"class":45},13,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100640753","short-course-regimens-for-ds-ptb-in-aids-patients-100640753","NCT07608172","Short-Course Regimens for DS-PTB in AIDS Patients","A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis in AIDS Patients","Inclusion Criteria:\n\n* Age ≥ 18 years, able to understand and sign the informed consent form.\n* Confirmed HIV infection.\n* Baseline CD4+ T-lymphocyte count \\\u003C 100 cells\u002FμL.\n* Confirmed active pulmonary tuberculosis.\n* Agree to receive antituberculosis treatment and antiretroviral therapy during the study period.\n\nExclusion Criteria:\n\n* Known or suspected resistance to any of the drugs in the regimen, including rifapentine, moxifloxacin, rifampicin, isoniazid, ethambutol, and pyrazinamide.\n* Body weight \\\u003C 40 kg.\n* Received the current tuberculosis treatment for more than 7 days.\n* Complicated with tuberculous meningitis or other severe forms of tuberculosis.\n* Severe liver dysfunction (ALT or AST \\> 5 times the upper limit of normal, ULN). - - Severe renal dysfunction (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n* Baseline electrocardiogram (ECG) showing QTc interval \\> 500 ms.\n* Pregnant or lactating women.\n* Presence of other conditions deemed inappropriate for study participation by the investigators.",{"count":78,"type":21},148,[80],"NA","This study adopts a multicenter, open-label, randomized controlled design, conducted across key designated AIDS diagnosis and treatment hospitals nationwide. It aims to compare the efficacy and safety of the 2HPMZ\u002F2HPM regimen versus the 2HRZE\u002F4HR regimen in treating HIV-associated drug-susceptible pulmonary tuberculosis (DS-TB) among patients with a CD4+ T-cell count \\\u003C 100 cells\u002FμL. A total of 148 participants will be enrolled and randomized 1:1 into two groups: 74 cases in the 2HPMZ\u002F2HPM group and 74 cases in the 2HRZE\u002F4HR group.",[83,27],"Tuberculosis in HIV-infected Individuals",[85,86,87],"Drug susceptible pulmonary tuberculosis","HIV-infected individuals","2HPMZ\u002F2HPM","NOT_YET_RECRUITING","2026-05-24",{"date":91,"type":38},"2026-05-27",{"date":93,"type":21},"2026-05-25",{"date":95,"type":21},"2028-12-31",{"name":97,"class":98},"Shanghai Public Health Clinical Center","OTHER_GOV",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100602908","phase-2-short-course-regimen-with-bedaquiline-moxifloxacin-and-pyrazinamide-for-early-bactericidal-activity-in-drug-susceptible-tuberculosis-100602908","NCT07129629","Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis","Beams","Inclusion Criteria:\n\n1. Age ≥18 years and ≤60 years\n2. Male or female\n3. Body weight 40-90 kg\n4. Capable of producing adequate sputum, with collection of at least 10ml overnight sputum\n5. Willing to participate in trial treatment and follow-up, with signed informed consent (legal guardian may sign for patients lacking civil capacity)\n6. Positive acid-fast bacilli smear microscopy of respiratory specimens (≥1+ according to WHO criteria) and positive rapid amplification test for Mycobacterium tuberculosis in respiratory specimens\n7. Rifampicin-susceptible based on molecular drug susceptibility testing or conventional drug susceptibility testing\n8. No anti-TB treatment for more than 3 days received within 6 months before the screening period\n9. Subjects whose imaging findings meet the diagnostic criteria for TB, as determined by the investigator\n10. Women of childbearing potential who have not undergone surgical sterilization must agree to use appropriate contraceptive methods\n\nExclusion Criteria:\n\n1. Evidence of concurrent extrapulmonary TB\n2. Subjects who have participated in other clinical studies within 8 weeks before the screening period\n3. Confirmed resistance of mycobacterium tuberculosis isolates to any of the following: Isoniazid, fluoroquinolones, revealed by molecular drug susceptibility testing\n4. Known allergy or intolerance to any study drug\n5. Patients who cannot receive oral therapy\n6. Abnormal liver function (alanine transaminase \\[ALT\\], alkaline phosphatase \\[ALP\\], or total bilirubin \\[TBil\\] exceeding 2 times the upper limit of normal) or known cirrhosis or known alcoholic hepatitis\n7. The hematology indicates white blood cells \\\u003C3.0×10⁹\u002FL, or hemoglobin \\\u003C80 g\u002FL, or platelets \\\u003C80×10⁹\u002FL\n8. The estimated glomerular filtration rate (eGFR) is less than 60 mL\u002Fmin\u002F1.73 m²\n9. The blood electrolyte test indicates a baseline serum potassium level less than 3.5 mmol\u002FL\n10. Subjects who have used drugs known to prolong the QTcF interval for more than 3 days within 30 days before the screening period (including but not limited to amiodarone, bisoprolol, chloroquine, chlorpromazine, cisapride, cyclobenzaprine, clarithromycin, digoxin, dofetilide, domperidone, ertapenem, ibutilide, levomethadone, methadone, pentamidine, quinidine, sotalol, sparfloxacin, thioridazine)\n11. Subjects with clinically significant ECG abnormalities as determined by the investigator, including but not limited to: baseline QTcF \\>450 ms for males or \\>470 ms for females, presence of second- or third-degree atrioventricular block, QRS duration \\>120 ms\n12. Combined heart failure, coronary artery disease, myocardial infarction, ventricular hypertrophy, clinically significant arrhythmia, poorly controlled hypertension-related cardiovascular disease\n13. Patients with known QT prolongation syndrome or a family history thereof\n14. Subjects who have used any drug or substance known to be a strong inhibitor of cytochrome P450 enzymes within 30 days before the screening period (including but not limited to ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin, fluvoxamine, warfarin, rivaroxaban, and other novel oral anticoagulants)\n15. Subjects with known bleeding disorders or family history of bleeding disorders\n16. Subjects with HIV infection\n17. Subjects with known optic neuritis, history of alcoholism, gout, epilepsy, mental illness, porphyria, myasthenia gravis, or malignant tumors\n18. Patients with type I or type II diabetes, or HbA1c ≥6.5%, or random blood glucose ≥11.1 mmol\u002FL with typical diabetic symptoms\n19. Pregnant or lactating patients","60 Years",{"count":108,"type":21},45,[24],"\\# Brief Summary\n\nThis study aims to evaluate the early bactericidal activity (EBA), safety, and tolerability of 4-month short-course regimens containing bedaquiline, moxifloxacin, and pyrazinamide in patients with drug-susceptible tuberculosis. This is a prospective, randomized, controlled, multicenter study planned to enroll 45 rifampicin-susceptible tuberculosis patients, who will be randomized in a 1:1:1 ratio to the BZMD group (bedaquiline + pyrazinamide + moxifloxacin + delamanid), BZMH group (bedaquiline + pyrazinamide + moxifloxacin + isoniazid), and standard control group. Subjects in the test groups will receive 17 weeks (4 months) of group-specific treatment regimens, while subjects in the control group will receive 26 weeks (6 months) of standard HRZE regimen treatment.\n\nThe primary endpoint is the change from baseline in log₁₀ colony-forming units (CFU) per milliliter of sputum specimen from Day 0 (pre-dose) to Day 14 of treatment (EBA CFU₀-₁₄), used to evaluate the early bactericidal activity of the drugs. Secondary endpoints include EBA CFU and EBA TTP (time to positive culture) at other time intervals, pharmacokinetic characteristics, sustained microbiological clearance rates, relapse rates, and safety indicators. The study will analyze the daily decline in log₁₀ CFU counts and daily increase in TTP using nonlinear mixed-effects models to reflect the bactericidal activity of the study regimens.\n\nThis study will help provide more effective and safer short-course treatment options for Chinese patients with drug-susceptible tuberculosis, thereby improving treatment adherence and treatment success rates, and providing scientific evidence for optimizing short-course treatment regimens for drug-susceptible tuberculosis.",[112,113],"Tuberculosis, Pulmonary","Drug-Susceptible Pulmonary Tuberculosis",[115,116,117,118,119,120],"Bedaquiline","Moxifloxacin","Pyrazinamide","Early Bactericidal Activity","Drug-Susceptible Tuberculosis","Short-course regimen","2025-08-18",{"date":123,"type":38},"2025-08-19",{"date":125,"type":21},"2025-08-20",{"date":127,"type":21},"2027-12-31",{"name":129,"class":45},"Shanghai Pulmonary Hospital, Shanghai, China"]