[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gates Medical Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":46},"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",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"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":55,"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],[60,61,30,31,32,33],"TBD09","oxazolidinone","2026-06-01",{"date":64,"type":38},"2026-06-03",{"date":66,"type":38},"2026-04-14",{"date":68,"type":21},"2026-11-05",{"name":44,"class":45},13,""]