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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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
Show all 12Show fewer
  • 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
Show all 25Show fewer
  • 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

+1 857 702 2108

clinical.trials@gatesmri.org

Gates MRI contact

+1-866-789-5757

13 sites in 1 country

South Africa13 sites, 12 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

    Recruiting

  • ONE MRI

    Cape Town, Western Cape, 7405

    Active, not 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

    Recruiting

Other trials in South Africa

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.

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 groups in NCT07525427
Study groupRoleWhat they receive
Group 1ExperimentalThe combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid
Receives: Drug: Bedaquiline, pretomanid and TBD09
Group 2ExperimentalThe combination of TBD09 (100 mg QD), bedaquiline and pretomanid
Receives: Drug: Bedaquiline, pretomanid and TBD09
Group 3ExperimentalThe combination of TBD09 (300 mg QD), bedaquiline and pretomanid
Receives: Drug: Bedaquiline, pretomanid and TBD09
Group 4ExperimentalThe combination of TBD09 (500 mg QD), bedaquiline and pretomanid
Receives: Drug: Bedaquiline, pretomanid and TBD09
Group 5Active comparatorThe 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.

  1. Bactericidal Activity

    Average daily change in MGIT sputum culture TTD from baseline to end-of-treatment (EOT)

    Measured: From randomization through Day 28 (EOT)

  2. Safety: SAEs

    Proportion of participants with this event

    Measured: Screening through Day 35 (EOS)

  3. Safety: TEAEs

    Proportion of participants with this event

    Measured: Screening through Day 35 (EOS)

  4. Safety: AESIs

    Proportion of participants with this event

    Measured: Screening through Day 35 (EOS)

  5. Safety: AEs leading to treatment discontinuation

    Proportion of participants with this event

    Measured: Screening through Day 35 (EOS)

Secondary outcomes (13)

  1. 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:

    1. Post-baseline result < lower limit of normal (LLN) among participants with baseline result > LLN (yes/no)
    2. Post-baseline result < 50% of LLN (yes/no)
    3. Post-baseline result ≥50% decrease relative to baseline (yes/no)

    Measured: Randomization through Day 35 (EOS)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. Bactericidal activity

    Proportion of participants with negative MGIT sputum cultures at D28

    Measured: Day 28 (EOT)

  8. Maximum plasma concentration (Cmax) of TBD09

    Concentrations of TBD09 administered in an investigational combination regimen.

    Measured: Day 1 and Day 28

  9. Time to maximum plasma concentration (Tmax) of TBD09

    Concentrations of TBD09 administered in an investigational combination regimen.

    Measured: Day 1 and Day 28

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted13 Apr 2026
  2. Study start14 Apr 2026
  3. Primary completion5 Nov 2026 (estimated)
  4. Study completion5 Nov 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gates MRI (+1 857 702 2108, clinical.trials@gatesmri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bactericidal Activity (time frame: From randomization through Day 28 (EOT)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07525427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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