Testing TBD09 with other drugs for lung tuberculosis
Tests TBD09 combined with other drugs in adults with drug-sensitive lung tuberculosis.
Plain-language title generated from the registry record
Registry title: Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Key facts
- Where
- Bethelsdorp, Brits, Cape Town, Durban, East London, George, Johannesburg, Pretoria, and Tembisa, South AfricaSee the 13 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07525427, who can take part
Where in South Africa
- CHRU @ Isango LethembaBethelsdorp, South AfricaTaking people
- Madibeng Centre for ResearchBrits, South AfricaTaking people
- BioMedical Research Institute - Stellenbosch University @ Tygerberg HospitalCape Town, South AfricaTaking people
- Desmond Tutu Health FoundationCape Town, South AfricaTaking people
- TASK Applied Science - Brookylyn Chest HospitalCape Town, South AfricaTaking people
- UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)Cape Town, South AfricaTaking people
- ONE MRICape Town, South AfricaNo longer taking part
- Enhancing Care Foundation at Wentworth HospitalDurban, South AfricaTaking people
- Synergy Biomedical Research Institute (SBRI)East London, South AfricaTaking people
- TASK Applied Science - EdenGeorge, South AfricaTaking people
- Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph HospitalJohannesburg, South AfricaTaking people
- Setshaba Research CenterPretoria, South AfricaTaking people
- The Aurum Institute TembisaTembisa, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gates Medical Research Institute
- Trial code
- NCT07525427
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age 18-65 years at consent; Body weight 35-100 kg at screening; Written informed consent obtained; Newly diagnosed rifampicin-sensitive pulmonary TB; Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra; ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result; Rifampicin sensitivity on molecular test; Chest X-ray consistent with TB (Investigator assessment); Able to spontaneously produce sputum; Reproductive requirements met; Women of childbearing potential: 2 approved contraceptive methods or abstinence; Males: contraception or abstinence through 90 days post-dose.
Exclusion: Prior anti-TB treatment for the current TB episode within 60 days; Prior medication active against Mtb within 3 months; Prior treatment completion for TB within 3 years; 2 or more prior episodes of TB; Current or recent systemic immunosuppressive therapy, including corticosteroids; Significant drug or alcohol abuse affecting compliance or safety; Clinically significant history of or current medical condition posing safety risk; If HIV positive:; Not on ARVs or taking ARVs for <3 months prior to screening OR; CD4+ count <200cells/uL at screening OR; HIV viral load >200 copies /mL at screening OR; AIDS infection or malignancies; Meets any of the following laboratory values during screening:; AST, ALT, or ALP ≥2.5× ULN; Total bilirubin ≥1.2× ULN; eGFR <60 mL/min/1.73 m²; Hemoglobin <9.0 g/dL (male) or <8.5 g/dL (female); White blood cell count <2,000/mm³; Absolute neutrophil count <800/mm³; Platelet count ≤100,000/mm³; Positive hepatitis B surface antigen; Positive hepatitis C antibody; HbA1c ≥8.0%; Evidence of extra-thoracic TB, per investigator judgement; Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment.