Drug Susceptible Pulmonary TuberculosisPhase 2NCT07525427
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
A Phase 2 study testing Bedaquiline, pretomanid and TBD09 and Bedaquiline, pretomanid and linezolid in people with Drug Susceptible Pulmonary Tuberculosis, run by Gates Medical Research Institute at 13 sites in South Africa.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Susceptible Pulmonary Tuberculosis
- What is being tested?
- Bedaquiline, pretomanid and TBD09 and Bedaquiline, pretomanid and linezolid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesSouth Africa
- Study dates
- 14 Apr 2026to 5 Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gates MRI contact
13 sites in 1 country
South Africa13 sites, 12 recruiting
- Recruiting
CHRU @ Isango Lethemba
Bethelsdorp, Gqeberha, 6003
Simone Faesen, MD, 27 41 811 0347, Simfaesen@witshealth.co.za
Thuso Malatsi, Tmalatsi@witshealth.co.za
- Recruiting
Madibeng Centre for Research
Brits, North West, 0250
Lindsey Faul, MD, +27 12 252 1140, lfaul@madibengresearch.co.za
Ralinah Maepa, rmaepa@madibengresearch.co.za
- Active, not recruiting
ONE MRI
Cape Town, Western Cape, 7405
- Recruiting
TASK Applied Science - Brookylyn Chest Hospital
Cape Town, Western Cape, 7405
Fairoez Ryklief, MD, 021 510 2209, dr.fairoez@task.org.za
Khomotso Zitha, k.zitha@taskclinical.com
- Recruiting
BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital
Cape Town, Western Cape, 7505
Andriette Hiemstra, MD, 021 938 9639, ahiemstra@sun.ac.za
Bernadine Fransman, bfransman@sun.ac.za
- Recruiting
UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
Cape Town, Western Cape, 7700
Rodney Dawson, MD, 27214067976, rodney.dawson@uct.ac.za
Shanice Johnson, shanice.johnson@uct.ac.za
- Recruiting
Desmond Tutu Health Foundation
Cape Town, Western Cape, 7750
Keren Middelkoop, MD, 717999262, Keren.Middelkoop@hiv-research.org.za
Jabulisile Zuma, Jabulisile.Zuma@hiv-research.org.za
- Recruiting
Enhancing Care Foundation at Wentworth Hospital
Durban, Bluff, 4052
Sundrapragasen (Sandy) Pillay, MD, +27 31 4611629, pillay@ecarefoundation.com
Penelope Madlala, pmadlala@ecarefoundation.com
- Recruiting
Synergy Biomedical Research Institute (SBRI)
East London, 5241
Mookho Malahleha, MD, 437222306, drmookho@sbri.org.za
Nqobile Msweli, nqobile@sbri.org.za
- Recruiting
TASK Applied Science - Eden
George, Central, 6529
Suzanne Staples, MD, 044 873 3395, s.staples@taskclinical.com
Amkelwa Dlunge, a.dlunge@taskclinical.com
- Recruiting
Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital
Johannesburg, Gauteng, 2092
Mohammed Rassool, MD, 112768800, mrassool@witshealth.co.za
Betty Matome, bmatome@witshealth.co.za
- Recruiting
Setshaba Research Center
Pretoria, Soshangue, 0152
Ntokozo Zuma-Gwala, MD, 073 476 1398, NZuma-Gwala@setshaba.org.za
Mohammed Osman, mosman@setshaba.org.za
- Recruiting
The Aurum Institute Tembisa
Tembisa, Gauteng, 1736
Mmatsie Manentsa, MD, 27828214157, mmanentsa@auruminstitute.org
Tebatso Matsepe, tmatsepe@auruminstitute.org
About this study
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
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.
- Conditions
- Drug Susceptible Pulmonary Tuberculosis
- Being tested
- Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and linezolid
- Keywords
- TBD09, oxazolidinone, bedaquiline, pretomanid, linezolid, drug-susceptible pulmonary tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedaquiline, pretomanid and TBD09Drug
Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and TBD09Drug
Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and TBD09Drug
Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and TBD09Drug
Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Bedaquiline, pretomanid and linezolidDrug
Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid Receives: Drug: Bedaquiline, pretomanid and TBD09 |
| Group 2 | Experimental | The combination of TBD09 (100 mg QD), bedaquiline and pretomanid Receives: Drug: Bedaquiline, pretomanid and TBD09 |
| Group 3 | Experimental | The combination of TBD09 (300 mg QD), bedaquiline and pretomanid Receives: Drug: Bedaquiline, pretomanid and TBD09 |
| Group 4 | Experimental | The combination of TBD09 (500 mg QD), bedaquiline and pretomanid Receives: Drug: Bedaquiline, pretomanid and TBD09 |
| Group 5 | Active comparator | The combination of linezolid (600 mg QD), bedaquiline and pretomanid Receives: Drug: Bedaquiline, pretomanid and linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bactericidal Activity
Average daily change in MGIT sputum culture TTD from baseline to end-of-treatment (EOT)
Measured: From randomization through Day 28 (EOT)
Safety: SAEs
Proportion of participants with this event
Measured: Screening through Day 35 (EOS)
Safety: TEAEs
Proportion of participants with this event
Measured: Screening through Day 35 (EOS)
Safety: AESIs
Proportion of participants with this event
Measured: Screening through Day 35 (EOS)
Safety: AEs leading to treatment discontinuation
Proportion of participants with this event
Measured: Screening through Day 35 (EOS)
Secondary outcomes (13)
Safety: Hematologic Effect
Proportion of participants who meet each of the following binary classifications of platelets, absolute neutrophil count (ANC), total white blood cell count (WBC), absolute lymphocyte count (ALC), and hemoglobin:
- Post-baseline result < lower limit of normal (LLN) among participants with baseline result > LLN (yes/no)
- Post-baseline result < 50% of LLN (yes/no)
- Post-baseline result ≥50% decrease relative to baseline (yes/no)
Measured: Randomization through Day 35 (EOS)
Safety: Visual Acuity Assessment
Proportion of participants with worsening of postbaseline visual acuity score of 2 lines or more in either eye using Snellen-type charts
Measured: Randomization through Day 35 (EOS)
Safety: Colour Vision Assessment
Proportion of participants with a new or worsening post-baseline color vision abnormality in either eye (by severity grade) using Ishihara plates
Measured: Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Proportion of participants with a reported new or worsening post-baseline peripheral neuropathy symptom on BPNS in either lower extremity (overall and by severity grade)
Measured: Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Proportion of participants with a new or worsening post-baseline peripheral neuropathy objective physical finding on BPNS in either lower extremity (overall and by severity grade)
Measured: Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Proportion of participants with new or worsening post-baseline peripheral neuropathy as defined by new/worsening symptom and new/worsening objective physical finding on BPNS in the same lower extremity (overall and by severity grade).
Measured: Randomization through Day 35 (EOS)
Bactericidal activity
Proportion of participants with negative MGIT sputum cultures at D28
Measured: Day 28 (EOT)
Maximum plasma concentration (Cmax) of TBD09
Concentrations of TBD09 administered in an investigational combination regimen.
Measured: Day 1 and Day 28
Time to maximum plasma concentration (Tmax) of TBD09
Concentrations of TBD09 administered in an investigational combination regimen.
Measured: Day 1 and Day 28
Area under the curve from 0 to 24 hours (AUC0-24) of plasma concentration of TBD09
Concentrations of TBD09 administered in an investigational combination regimen.
Measured: Day 1
Area under the curve from 0 to infinity (AUC0-inf) of plasma concentration of TBD09
Concentrations of TBD09 administered in an investigational combination regimen.
Measured: Day 28
Area under the curve over the dosing interval on day 28 (AUCtau) of plasma concentration of TBD09
Concentrations of TBD09 administered in an investigational combination regimen.
Measured: Day 28
Accumulation ratio (Area under the curve from 0 to the end of the dosing interval (AUCtau) / AUC0-24), Day 28 vs Day 1 of plasma concentration of TBD09
Concentrations of TBD09 administered in an investigational combination regimen.
Measured: Day 1 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start14 Apr 2026
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Susceptible Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525427
- Sponsor's protocol ID
- Gates MRI-TBD09-201
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes