Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT03988933
Eligibility Criteria:
Inclusion Criteria:
* Adults, and children aged 10 and older who weigh at least 25kg.
* Evidence of latent TB infection: positive tuberculin skin test (5mm or greater or 10mm or greater, based on National guidelines) or positive interferon gamma release assay.
* Eligible to take latent TB treatment according to Canadian guidelines in the Canadian sites, and according to World Health Organization (WHO) guidelines in the international sites (this includes household contacts, other contacts, HIV infected, other causes of immune suppression, fibronodular disease on chest-x ray (CXR), or other indication).
Exclusion Criteria:
* Children aged 0-9 and children aged 10 or older who weigh less than 25kg
* Pregnancy
* Baseline AST or ALT that is at least 3 times higher than upper limit of normal
* Baseline Grade 3-4 abnormalities of hematological tests (WBC, platelets or hemoglobin).
* Prior treatment for latent or active TB.
* Rifampin contra-indicated - due to potential drug interactions that are considered too important, or difficult to manage, by health care provider; or due to history of allergy/ hypersensitivity to rifampin, rifabutin or rifapentine.
* Household contacts of index TB patients with confirmed, or suspected rifampin resistant TB.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT03988933
Study Brief:
Protocol Section:
NCT03988933