TBD09 combined with other TB medicines to kill bacteria in pulmonary TB
Official title: 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
Run by Gates Medical Research Institute · NCT07525427 · Data updated 2026-11-12
This test will see if adding TBD09 to other TB medicines helps clear the infection in adults with drug‑sensitive pulmonary tuberculosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Gates Medical Research Institute Academic / other |
| Locations | 13 sites (Durban, Bluff and 12 other locations) |
| Status | Recruiting |
| Started | April 14, 2026 |
| Main results expected | November 5, 2026 |
| Study ends | November 5, 2026 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07525427 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with newly diagnosed rifampicin‑sensitive pulmonary TB who can produce sputum, meet weight and contraceptive requirements, and have no recent TB treatment are ideal candidates.
✕Probably not a fit
People with rifampicin‑resistant or extrapulmonary TB, recent or multiple prior TB treatments, or significant medical comorbidities are unlikely to receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial tests the bactericidal activity of TBD09 when given with other active TB medicines in adults with rifampicin‑sensitive pulmonary tuberculosis. Participants receive combination regimens that include bedaquiline and pretomanid, with some arms substituting or adding an oxazolidinone (linezolid or TBD09), and will provide serial sputum samples to measure bacterial killing. Eligible adults (18–65 years) must be newly diagnosed with rifampicin‑sensitive pulmonary TB, meet weight and reproductive criteria, and have no recent anti‑TB therapy; those with recent or multiple prior TB episodes or extrapulmonary disease are excluded. Safety data and early bactericidal activity outcomes will inform whether TBD09 should proceed to larger efficacy trials.
Why it matters
Potential benefit: If successful, this could lead to a more effective regimen that kills TB bacteria faster and may shorten treatment for drug‑sensitive pulmonary tuberculosis.
How similar studies have gone: Regimens combining bedaquiline, pretomanid and oxazolidinones have shown promise in drug‑resistant TB, but TBD09 itself is a novel oxazolidinone with limited clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Prior anti-TB treatment for the current TB episode within 60 days * Prior medication active against Mtb within 3 months * Evidence of extra-thoracic TB, per investigator judgement * Prior treatment completion for TB within 3 years * 2 or more prior episodes of TB * 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% * Current or recent systemic immunosuppressive therapy, including corticosteroids * Significant drug or alcohol abuse affecting compliance or safety * Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment
Where it's running
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Enhancing Care Foundation at Wentworth Hospital
Durban, Bluff, South Africa Recruiting -
TASK Applied Science - Eden
George, Central, South Africa Recruiting -
Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital
Johannesburg, Gauteng, South Africa Recruiting -
The Aurum Institute Tembisa
Tembisa, Gauteng, South Africa Recruiting -
CHRU @ Isango Lethemba
Bethelsdorp, Gqeberha, South Africa Recruiting -
Madibeng Centre for Research
Brits, North West, South Africa Recruiting
Show 7 more locations
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Setshaba Research Center
Pretoria, Soshangue, South Africa Recruiting -
TASK Applied Science - Brookylyn Chest Hospital
Cape Town, Western Cape, South Africa Recruiting -
BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital
Cape Town, Western Cape, South Africa Recruiting -
UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
Cape Town, Western Cape, South Africa Recruiting -
Desmond Tutu Health Foundation
Cape Town, Western Cape, South Africa Recruiting -
Synergy Biomedical Research Institute (SBRI)
East London, South Africa Recruiting -
One MRI
Cape Town, Western Cape, South Africa Active not recruiting
Study contacts
- Study coordinator: Gates MRI
- Email: clinical.trials@gatesmri.org
- Phone: +1 857 702 2108
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.