Shorter and Safer Treatment Regimens for Latent TB

Recruiting Phase 2 Phase 3 Interventional Study
Tuberculosis Infection, Latent
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
5 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
1,800 (estimated)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
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About This Trial
Our study rationale is based on: 1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe; 2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs; 3. 4 months of Rifampin 10mg/kg (4R10) is the safest regimen, but is completed by \<80% of patients; 4. The safety of 2 months of Rifampin 20mg/k…
Trial Locations
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Eligibility Criteria
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 Manufacture…
Contacts

Dick Menzies, MD

514-934-1934

dick.menzies@mcgill.ca

CONTACT

Chantal Valiquette

514-934-1934

chantal.valiquette@affiliate.mcgill.ca

CONTACT