[{"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:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100633341","phase-2-bactericidal-activity-of-tbd09-in-combination-with-other-drugs-in-pulmonary-tuberculosis-100633341",false,"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","ALL","18 Years","65 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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],"Drug Susceptible Pulmonary Tuberculosis",[29,30,31,32,33,34],"TBD09","oxazolidinone","bedaquiline","pretomanid","linezolid","drug-susceptible pulmonary tuberculosis","RECRUITING","2026-07-29",{"date":38,"type":39},"2026-07-30","ACTUAL",{"date":41,"type":39},"2026-04-14",{"date":43,"type":21},"2026-11-05",{"name":45,"class":46},"Gates Medical Research Institute","OTHER",13,""]