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Could TB treatment be cut from 6 months to 17 weeks?

NCT ID NCT05766267

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

This study tests whether two new 17-week drug combinations can treat pulmonary tuberculosis as effectively as the standard 6-month regimen. About 288 people with TB will receive one of three daily pill regimens. The goal is to see if shorter treatment can clear the infection faster and with fewer side effects, potentially making it easier for patients to stick with therapy.

What this could mean

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

Active substance
Combination of bedaquiline, moxifloxacin, pyrazinamide, plus either rifabutin or delamanid
What this could lead to
If successful, this could lead to a shorter, 17-week treatment for tuberculosis, making it easier for patients to complete therapy and reduce the spread of the disease.
What could go wrong
This is a mid-stage trial with only 288 participants, so results may not apply to everyone. The shorter regimens might be less effective or cause more side effects than the standard 6-month treatment.

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

About 288 people

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

Started

Nov 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

12 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. Pulmonary tuberculosis with or without suspected or proven concomitant extrapulmonary tuberculosis outside the central nervous system or bones 2. Acid-fast bacilli (AFB) seen in an expectorated sputum specimen at least 1+ or positive GeneXpert (or GeneXpert Ultra) for M. tuberculosis, with semiquantitative results of "medium" or "high". 3. Age ≥12 years 4. Documentation of negative HIV status within the past 3 months prior to enrollment or documentation confirming HIV infection. 5. For participants with HIV: 1. current use of dolutegravir-based ART (Anti Retroviral Therapy), or ability and willingness to start or transition to a dolutegravir-based antiretroviral therapy regimen 2. CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to study enrollment 6. Written informed consent/assent 7. Karnofsky score of at least 60 ("requiring some help, can take care of most personal requirements") 8. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period. 9. For all women who have not undergone a surgical sterilization procedure or who do not meet the study definition of post-menopausal, a negative pregnancy test at or within seven (7) days prior to screening 10. For all individuals of child-bearing potential who are not surgically sterilized, agreement to practice a reliable method of contraception (barrier method or non-hormonal intrauterine device) or abstain from sexual activity that could lead to pregnancy while receiving study drug treatment and for 30 days after stopping study treatment Exclusion Criteria: 1. Pregnant or breast-feeding 2. More than 5 days of tuberculosis treatment in the previous 6 months 3. Previous treatment with any drug or combination of drugs known to have activity against M. tuberculosis (e.g., isoniazid, rifamycins, pyrazinamide, ethambutol, fluoroquinolones, etc.) for more than five days in the thirty days prior to enrollment 4. Unable to take oral medications 5. Hypersensitivity or previous intolerance to any of the study drugs 6. Current or planned use of medications that have unacceptable drug-drug interactions with any of the study drugs during study treatment 7. Suspected or proven central nervous system tuberculosis 8. Suspected or proven bone tuberculosis 9. Screening ECG with QTcF \>450 for men or \>470 for women (Note: in case of hypokalemia or hypomagnesemia, ECG can be repeated following electrolyte supplementation) 10. Clinically significant ECG abnormality in the opinion of the site investigator, including but not limited to second or third degree atrioventricular (AV) block, prolongation of the QRS complex over 120 ms (in both male and female participants), or clinically important arrhythmia 11. Current clinically relevant cardiovascular disorder in the opinion of the site investigator, including but not limited to heart failure, coronary heart disease, arrhythmia, or tachyarrhythmia 12. Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling) 13. History of aortic aneurysm or dissection 14. Hepatic cirrhosis or other serious liver disease 15. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest. 16. Laboratory parameters done at or within 14 days prior to screening: 1. Serum or plasma alanine aminotransferase greater than 3 times the upper limit of normal 2. Serum or plasma total bilirubin greater than 2.5 times the upper limit of normal 3. Serum creatinine \> 2 times the upper limit of normal 4. Platelet count \< 75,000 cells/mm3 5. Absolute neutrophil count \<1,000 cells/mm3 6. Serum or plasma potassium \<3.5 meq/L (note: potassium may be repleted and test repeated) 17. Weight less than 40.0 kg 18. Known or suspected resistance to isoniazid or rifamycins (by phenotypic or molecular test) 19. Previously enrolled in this study or currently enrolled in another therapeutic clinical trial that, in the investigator's judgment, would compromise study integrity or participant safety 20. Current or planned incarceration or other involuntary detention.

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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

  • McGill University Health Centre

    Montreal, Canada

  • TBTC Site 09 University of Cape Town Lung Institute (Pty) Ltd

    Mowbray, Cape Town, 7700, South Africa

  • TBTC Site 26 Seattle & King County TB Control Program

    Seattle, Washington, 98104, United States

  • TBTC Site 30 Uganda-Case Western Reserve Research Collaboration

    Kampala, Uganda

  • TBTC Site 45 Les Centres Gheskio (INLR)

    Port-au-Prince, Ouest, HT6110, Haiti

  • TBTC Site 67 GHESKIO centers IMIS

    Port-au-Prince, Ouest, HT 6124, Haiti

  • TBTC Site 76 CAB-V. Can Tho Province, Vietnam - Thot Not District TB Unit

    Can Tho, Can Tho City, 70000, Vietnam

  • Vancouver, British Columbia Centre for Disease Control

    Vancouver, Canada

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