Shorter TB prevention regimens put to the test in major trial
NCT ID NCT06498414
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 1,800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
14 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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BCCDC TB clinic
RECRUITINGVancouver, British Columbia, Canada
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Can Tho Lung Hospital
RECRUITINGCan Tho, Vietnam
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Centre National Hospitalier Universitaire de Pneumo Phtisiologie de Cotonou (CNHU-PPC)
NOT_YET_RECRUITINGCotonou, Benin
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Hopital du Sacré-Coeur de Montreal
RECRUITINGMontreal, Quebec, H4J 1C5, Canada
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MUHC
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Manaus
RECRUITINGManaus, Brazil
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National Lung Hospital
RECRUITINGHanoi, Vietnam
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St. Michael's Hospital
RECRUITINGToronto, Ontario, M5B1W8, Canada
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The Governors of the University of Alberta
RECRUITINGEdmonton, Alberta, T6G 2C8, Canada
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Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB research clinic)
RECRUITINGBandung, Indonesia
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University Health Network
RECRUITINGToronto, Ontario, M6M2J5, Canada
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University of Manitoba
RECRUITINGWinnipeg, Manitoba, Canada
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University of Ottawa
RECRUITINGOttawa, Ontario, Canada
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Unviversity of Calgary
RECRUITINGCalgary, Alberta, Canada
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Other studies related to the condition(s) this trial covers.
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