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Can a 4-Drug combo cut TB treatment time in half?

NCT ID NCT03338621

Disease control Sponsor: Global Alliance for TB Drug Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests a new combination of four drugs, called BPaMZ, for treating tuberculosis. People with drug-sensitive TB receive BPaMZ for 4 months, compared to the standard 6-month regimen. People with drug-resistant TB receive BPaMZ for 6 months. The study measures how well the treatment clears the bacteria and prevents relapse over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of four drugs: bedaquiline, pretomanid, moxifloxacin, and pyrazinamide (BPaMZ)
What this could lead to
If successful, this could shorten tuberculosis treatment from 6 months to 4 months for drug-sensitive cases, and offer a shorter, all-oral option for drug-resistant TB.
What could go wrong
The trial is in Phase 2/3, so results are not yet confirmed. The new regimen may not be as effective or safe as standard care, and side effects could limit its use.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

455 people

The number who actually took part.

Started

Jul 2018

Finished

Jun 2022

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 years and older

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: * Sputum positive for tubercule bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease \[IUATLD\]/WHO scale (Appendix 1) on smear microscopy) at the trial laboratory. * Participants with one of the following pulmonary TB conditions: DS-TB treatment arm participants should be: * sensitive to rifampicin and isoniazid by rapid sputum based test AND * either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB. DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid. * Of non-childbearing potential or willing to practice effective methods of birth control * Body weight (in light clothing and no shoes) ≥ 30 kg. * Completed informed consent form Exclusion Criteria: * Karnofsky score \<60% * Any risk factor for QT prolongation * Any planned contraindicated medicines * Resistant to fluoroquinolones (rapid, sputum-based molecular screening tests). Any of the following lab toxicities/abnormalities: * CD4+ count \< 100 cells/µL (HIV infected participants) * platelets \<75,000/mm³ * creatinine \>1.5 times upper limit of normal (ULN) * eGFR ≤ 60 mL/min * haemoglobin \<8.0 g/dL * serum potassium less than the lower limit of normal for the laboratory. * GGT: greater than 3 x ULN * AST: ≥3.0 x ULN to be excluded; * ALT: ≥3.0 x ULN to be excluded * ALP: ≥3.0 x ULN to be excluded * Total bilirubin: \>1.5 x ULN to be excluded; * Direct bilirubin: greater than 1x ULN to be excluded

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Conditions

The condition(s) this trial relates to.

drug-resistant tuberculosis multidrug-resistant tuberculosis pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

Drug-resistant tuberculosis Tuberculosis Tuberculosis, MDR Tuberculosis, multidrug-resistant Tuberculosis, pulmonary

Contacts and locations

Locations

  • CHRU, Empilweni TB Hospital

    Port Elizabeth, 7070, South Africa

  • CHRU, Helen Joseph Hospital

    Johannesburg, 2092, South Africa

  • CHRU, King Dinuzulu

    Durban, 4015, South Africa

  • Case Western Reserve University

    Kampala, 2109, Uganda

  • Central TB Research Institute of the Federal Agency of Scientific Organizations

    Moscow, 107564, Russia

  • Enhancing Care Foundation

    Durban, 4001, South Africa

  • Evandro Chagas

    Rio de Janeiro, Brazil

  • FIOCRUZ

    Rio de Janeiro, Brazil

  • Ifakara Health Institute

    Bagamoyo, Tanzania

  • Institut Perubatan Respiratori

    Kuala Lumpur, Malaysia

  • Kilimanjaro Clinical Research Institute

    Moshi, Tanzania

  • Lung Center of Philippines

    Manila, 1104, Philippines

  • Madibeng Centre for Research

    Brits, 0250, South Africa

  • Moscow City Research and Practice Tuberculosis Treatment Centre

    Moscow, 107014, Russia

  • Mwanza Intervention Trials Unit

    Mwanza, Tanzania, Tanzania

  • NIMR-Mbeya

    Mbeya, Tanzania

  • National Center for Tuberculosis and Lung Diseases

    Tbilisi, K'alak'i T'bilisi, 0101, Georgia

  • PHRU, Tshepong Hospital

    Klerksdorp, 2571, South Africa

  • Research Institute of Phthisiopulmonology of I. M. Sechenov First Moscow State Medical University

    Moscow, 119991, Russia

  • Research Institute of the Phthisiopulmonology

    Saint Petersburg, 191036, Russia

  • Setshaba Research Centre

    Soshanguve, 0152, South Africa

  • TASK

    Cape Town, 7530, South Africa

  • THINK

    Pietermaritzburg, KwaZulu-Natal, 3216, South Africa

  • Tropical Disease Foundation

    Manila, 1230, Philippines

  • University of Cape Town Lung Institute

    Cape Town, 7700, South Africa

  • Ural Research Institute of Phthisiopulmonology

    Yekaterinburg, 620039, Russia

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