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Shorter TB prevention regimens put to the test in major trial

NCT ID NCT06498414

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study aims to find a shorter, safer treatment for latent tuberculosis (TB) infection to prevent it from becoming active disease. About 1800 adults and children with a positive TB test will try one of several daily pill regimens lasting 1 to 4 months. The goal is to identify a treatment that is as safe and effective as the current standard but easier to complete.

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 1,800 people

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

Started

Jun 2025

Expected to finish

Jun 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

5 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: * Adults, and children aged ≥5 years with weight of \> 15Kg. * Positive test for TB infection: either Tuberculin test (\>5mm, or \>10mm, based on epidemiologic and clinical factors and interpreted following local guidelines) or interferon gamma release assay based on Manufacturer's criteria; and, * Recommended for Tuberculosis Preventive Treatment (TPT), following Canadian guidelines (for Canadian sites), and World Health Organization (WHO) guidelines (for international sites). Exclusion Criteria: * Current tuberculosis (TB) disease - detected pre-enrolment with symptom screen, chest x-ray, and confirmatory microbiological (culture or genotypic) testing as needed; Prior to referral to research staff (research clinic) for consideration as potential participants, all persons must undergo symptoms screen and a chest Xray. If chest Xray is not available, then a negative results from a GeneXpert MTb RIF Ultra of spontaneous (expectorated) sputum will be considered sufficient to exclude TB disease pre-referral. If Chest Xray is abnormal or symptoms consistent with TB disease are present then at least two AFB smears and mycobacterial cultures must be done, and must be negative, or one GeneXpert MTb Rif Ultra must be negative before enrolment * Children aged 0-4 years; * Persons weighing \<15 kg. * Women who are pregnant or breast-feeding; * Women of child-bearing potential and not willing to take an effective form of contraception (non-hormonal) during the treatment phase; * Documented prior treatment for tuberculosis (TB) infection or disease; * Pre-enrolment - alanine transaminase (ALT), White Blood Cells, platelets or hemoglobin that correspond to a Grade 3 adverse event (AE); * Rifampin or rifapentine contra-indicated - due to allergy/hypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage; * Have a prolonged QT interval on routine ECG pre-enrolment or take any medications that may prolong the QT interval and that are not recommended to take with a fluroquinolone. (See APPENDIX 5 in supplement for list of medications contra-indicated to take with Levofloxacin); * Household contacts (HHC) of index TB patients with phenotypic or genotypic resistance to Rifampin or Levofloxacin. HHC may be enrolled, then excluded post-randomization, if resistance is identified later. Note that all sites routinely test Rifampin resistance in all people newly diagnosed to have TB disease, but do not test routinely for susceptibility to Levofloxacin unless Rifampin resistance is detected. Hence HHCs may be enrolled if their Index TB patient is Rifampin susceptible, even if Drug Susceptibility Testing to Levofloxacin is not done and/or not available.

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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.

How to take part

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

  1. The places running it

    14 sites in 5 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

  • BCCDC TB clinic

    RECRUITING

    Vancouver, British Columbia, Canada

  • Can Tho Lung Hospital

    RECRUITING

    Can Tho, Vietnam

  • Centre National Hospitalier Universitaire de Pneumo Phtisiologie de Cotonou (CNHU-PPC)

    NOT_YET_RECRUITING

    Cotonou, Benin

  • Hopital du Sacré-Coeur de Montreal

    RECRUITING

    Montreal, Quebec, H4J 1C5, Canada

  • MUHC

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Manaus

    RECRUITING

    Manaus, Brazil

  • National Lung Hospital

    RECRUITING

    Hanoi, Vietnam

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B1W8, Canada

  • The Governors of the University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2C8, Canada

  • Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB research clinic)

    RECRUITING

    Bandung, Indonesia

  • University Health Network

    RECRUITING

    Toronto, Ontario, M6M2J5, Canada

  • University of Manitoba

    RECRUITING

    Winnipeg, Manitoba, Canada

  • University of Ottawa

    RECRUITING

    Ottawa, Ontario, Canada

  • Unviversity of Calgary

    RECRUITING

    Calgary, Alberta, Canada

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