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Can a shorter TB drug combo beat Drug-Resistant TB?

NCT ID NCT05007821

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two different doses of the antibiotic linezolid, combined with three other drugs (bedaquiline, delamanid, and clofazimine), in 138 people with drug-resistant pulmonary tuberculosis. The goal was to see which dose worked better at clearing the infection and was easier to tolerate. Researchers also measured drug levels in the blood to understand how the body processes the medicines.

What this could mean

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

Active substance
Linezolid, bedaquiline, delamanid, and clofazimine (antibiotic combination)
What this could lead to
If successful, this could help identify a safer, shorter treatment regimen for drug-resistant tuberculosis, reducing side effects and improving cure rates.
What could go wrong
This is a phase 2 trial with only 138 participants, so results are preliminary. The higher linezolid dose may cause more side effects, and the regimen may not work for all types of drug-resistant TB.

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

138 people

The number who actually took part.

Started

Sep 2022

Finished

Jan 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: 1. Newly diagnosed pulmonary drug-resistant tuberculosis (DR-TB), with resistance to at least rifampicin or rifampin (which is a drug used in the therapy of tuberculosis) confirmed from a sputum specimen collected within 60 days prior to entry. 2. HIV-1 infection status documented as either absent or present. 3. For participants living with HIV, either currently on an antiretroviral therapy (ART) regimen or willing and able to start ART within 30 days after entry. 4. Efavirenz or etravirine (drugs used to treat HIV) must be discontinued prior to a participant's starting anti-TB medications. For participants on efavirenz or etravirine, they must be willing and able to discontinue these at least 7 days prior to initiating study TB medications. 5. For participants living with HIV, CD4+ cell (a type of white blood cell) count greater than or equal to 50 cells/mm3 obtained within 60 days prior to study entry. 6. For females of reproductive potential, negative serum or urine pregnancy test. 7. Females of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use two of the following forms of birth control while receiving TB study medications and for 30 days after stopping study medications: * Male or female condoms * Diaphragm or cervical cap (with spermicide, if available) * Intrauterine device (IUD) or intrauterine system (IUS) * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants) 8. Appropriate laboratory values as determined by the study doctor obtained within 14 days prior to entry. 9. Karnofsky performance score (an assessment tool for functional impairment) greater than or equal to 50 within 30 days prior to entry. 10. Ability and willingness of candidate and/or legal guardian/representative to provide informed consent and meet requirements for the study. 11. Chest X-ray obtained within 30 days prior to entry. Exclusion Criteria: 1. Documentation of clinically significant (as judged by the study doctor) active infections (including HIV-related opportunistic infections) other than TB and HIV requiring treatment within 30 days prior to entry. 2. Evidence of clinically significant (as judged by the study doctor) metabolic, gastrointestinal, cardiovascular, musculoskeletal, ophthalmological, pulmonary, neurological, psychiatric, endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) that would interfere with study medications or procedures. 3. Inability to take oral medications. 4. Suspected or documented TB involving the central nervous system, clinically significant renal TB or TB pericarditis, or current extrapulmonary TB involving other organ systems that might interfere with study medications or procedures, as judged by the study doctor. 5. Prior treatment with one or more of the study drugs at any time in the past for an episode of DR-TB that is not the qualifying episode or treatment for more than 7 cumulative days with one or more of the study drugs within 30 days prior to entry for the qualifying episode of DR-TB. 6. History of allergy or hypersensitivity to any of the study drugs or medications in the same class as the study drugs. 7. Known or suspected current alcohol and/or drug abuse that is, in the opinion of the study doctor, sufficient to compromise the safety and/or cooperation of the participant. 8. Receipt of any investigational drugs within 60 days prior to entry. 9. Known history of prolonged QT syndrome (heart rhythm condition that can potentially cause fast, chaotic heartbeats) or current prolonged QT interval on screening electrocardiogram (a medical test that detects cardiac (heart) abnormalities). 10. Known history of clinically significant cardiac arrhythmia (a condition in which the heart beats with an irregular or abnormal rhythm) requiring medication or clinically significant electrocardiogram (ECG) abnormality, in the opinion of the study doctor, within 60 days prior to entry. 11. Pregnancy or current breastfeeding, or intent to become pregnant and/or breastfeed while on study treatment. 12. Current use of monoamine oxidase inhibitors (type of medication used to treat depression) or use within 30 days prior to entry. 13. Current use of serotonergic agents including SSRI/SNRI antidepressants or prior use within 30 days prior to entry. 14. Known history of optic neuropathy (damage to the optic nerve in your eye) of any grade as diagnosed by an ophthalmologist. 15. Current peripheral neuropathy (when nerves are damaged or destroyed and can't send messages from the brain and spinal cord to the muscles, skin and other parts of the body) with severe paresthesias ("pins and needles") and/or mild weakness or worse (Grade ≥2.). 16. Weight less than 35 kg (77 lbs). 17. Currently taking other prohibited medications.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Barranco CRS (Site ID: 11301)

    Lima, 15063, Peru

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site ID: 31784)

    Chiang Mai, 50200, Thailand

  • De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) (Site ID: 31981)

    Cavite, 4114, Philippines

  • Durban International CRS (Site ID: 11201)

    Durban, KwaZulu-Natal, 4052, South Africa

  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site ID: 31730)

    Port-au-Prince, HT-6110, Haiti

  • Gaborone CRS (Site ID: 12701)

    Gaborone, South-East District, Botswana

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101)

    Rio de Janeiro, 21040-360, Brazil

  • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site ID: 30022)

    Port-au-Prince, HT-6110, Haiti

  • Rustenburg CRS (Site ID: 31684)

    Rustenburg, North West, 0300, South Africa

  • South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site ID: 31793)

    Cape Town, Western Cape, 7705, South Africa

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802)

    Pathum Wan, Bangkok, 10330, Thailand

  • University of Cape Town Lung Institute (UCTLI) CRS (Site ID: 31792)

    Cape Town, Western Cape, 7700, South Africa

  • Wits Helen Joseph Hospital CRS (Wits HJH CRS) (Site ID: 11101)

    Johannesburg, Gauteng, 2092, South Africa

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