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Could a shorter TB course work for those with unclear test results?

NCT ID NCT07163143

Disease control Sponsor: University College, London 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at people who have TB-like changes on chest X-rays but negative sputum tests. It compares different treatment lengths (8 to 24 weeks) versus close monitoring without immediate treatment. The goal is to find the shortest effective treatment and understand who really needs it. About 784 participants will be followed for 78 weeks.

What this could mean

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

Active substance
Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (standard TB drugs)
What this could lead to
If successful, this could show that a shorter course of TB drugs (8 weeks instead of 24) is just as effective for people with unclear TB, reducing treatment burden.
What could go wrong
This is a Phase 3 trial, but it's still early. The shorter treatment might not work as well, and some people may need longer therapy. Also, the deferred monitoring group carries a risk of disease progression.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 784 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Apr 2029

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

16 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. Aged ≥16 years old on day of randomisation 2. ≥25kg in weight on day of randomisation 3. Participation in community or facility-based active case finding for TB by CXR 4. Digital CXR with Computer Aided Detection software score above threshold for sputum investigation for Mtb according to local guidance ≤21 days prior to randomisation 5. Attempted sputum collection for testing by WHO approved rapid molecular test for Mtb at active case finding and at screening Exclusion Criteria: 1. Sputum sample from active case finding or screening confirmed as positive for Mtb by WHO approved rapid molecular test for Mtb 2. Previous history of pulmonary TB 3. TB preventive therapy taken within the last 6 months 4. \>1 dose of treatment with anti-tuberculous activity taken in the 21 days prior to randomisation 5. HIV infected, unless CD4 ≥200 cells/mm3 and on anti-retroviral therapy for at least 8 weeks 6. Pregnancy (confirmed by high sensitivity urine test) 7. Contraindication to study drug 8. Investigator concern for potential extra-pulmonary TB with the exceptions of (a) intrathoracic lymphadenopathy; and/or (b) small pleural effusion of limited extent, neither felt to require invasive diagnostic sampling 9. CXR changes considered more likely to relate to a condition other than untreated TB by investigator 10. Investigator assessment of an immediate requirement for full 24-weeks standard TB treatment 11. Investigator assessment of unacceptable risks to potential participant from study entry 12. No fixed home address 13. Unable to participate in the full duration of study follow-up

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

Tuberculosis (TB)

How to take part

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

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Bulawayo City Health

    Bulawayo, Zimbabwe

  • Clinical HIV Research Unit, Wits Health Consortium

    Johannesburg, South Africa

  • National University of Medical Sciences

    Islamabad, Pakistan

  • The Aurum Institute

    Johannesburg, South Africa

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