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New TB combo drug trial aims to shorten treatment

NCT ID NCT07525427

Disease control Sponsor: Gates Medical Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study tests whether a new drug called TBD09, when used with other TB medicines, is safe and works well in adults with drug-sensitive tuberculosis (TB). About 150 people will take part. The main goals are to see how quickly the drug combination kills TB bacteria and to check for any side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug susceptible pulmonary tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital

    RECRUITING

    Cape Town, Western Cape, 7505, South Africa

  • CHRU @ Isango Lethemba

    RECRUITING

    Bethelsdorp, Gqeberha, 6003, South Africa

  • Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital

    RECRUITING

    Johannesburg, Gauteng, 2092, South Africa

  • Desmond Tutu Health Foundation

    RECRUITING

    Cape Town, Western Cape, 7750, South Africa

  • Enhancing Care Foundation at Wentworth Hospital

    RECRUITING

    Durban, Bluff, 4052, South Africa

  • Madibeng Centre for Research

    RECRUITING

    Brits, North West, 0250, South Africa

  • ONE MRI

    ACTIVE_NOT_RECRUITING

    Cape Town, Western Cape, 7405, South Africa

  • Setshaba Research Center

    RECRUITING

    Pretoria, Soshangue, 0152, South Africa

  • Synergy Biomedical Research Institute (SBRI)

    RECRUITING

    East London, 5241, South Africa

  • TASK Applied Science - Brookylyn Chest Hospital

    RECRUITING

    Cape Town, Western Cape, 7405, South Africa

  • TASK Applied Science - Eden

    RECRUITING

    George, Central, 6529, South Africa

  • The Aurum Institute Tembisa

    RECRUITING

    Tembisa, Gauteng, 1736, South Africa

  • UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)

    RECRUITING

    Cape Town, Western Cape, 7700, South Africa

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