Latent tuberculosis infection Infections and Infestations Tuberculosis
Conditions
Interventions
Amended as of 12/06/2009:
Rifampin (drug) and isoniazid (drug). The dosage of the medication is determined according to the weight of the subject:
Isoniazid: once per d
Sponsors
The Research Institute of the McGill University Health Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current information as of 31/08/2010: Adults (aged greater than 18 years, either sex) with documented positive tuberculin skin test (TST) (or in the absence of a TST, a documented positive Quantiferon test [QFT]) and prescribed 9INH for LTBI, following authoritative recommendations. Initial information at time of registration: Adults (aged greater than 18 years, either sex) with documented positive tuberculin skin test (TST) and prescribed 9INH for LTBI, following authoritative recommendations.
Exclusion criteria
Exclusion criteria: 1. Patients who were contacts of TB cases known to be resistant to INH, RIF, or both (i.e. multi-drug resistant [MDR]) 2. Known human immunodeficiency virus (HIV)-infected individuals on anti-retroviral agents whose efficacy would be substantially reduced by rifampin, unless therapy can safely be changed to agents not affected by rifampin 3. Pregnant women - rifampin and INH are considered safe in pregnancy, but therapy is usually deferred until 2 - 3 months post-partum to avoid foetal risk and the potential for increased hepato-toxicity immediately post-partum 4. Patient on any medication with clinically important drug interactions with INH or RIF, which their physician believes would make either arm contra-indicated 5. History of allergy/hypersensitivity to INH or to rifampin, rifabutin or rifapentine 6. Active TB. Patients initially suspected to have active TB can be randomised once this has been excluded. 7. Persons who have already started LTBI therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the cumulative incidence during 28 months after randomisation, of confirmed active tuberculosis (TB) among all persons randomised (effectiveness, using intention to treat analysis) to 4RIF and 9INH | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/07/2012: 1. Compare the cumulative incidence of confirmed active TB among those who took at least 80% of doses of the LTBI treatment to which they were randomized, in less than 120% of the allowed time (i.e. efficacy). 2. Compare the cumulative incidence of probable, as well as confirmed active TB between patients randomized to the two regimens during 28 months following randomization. 3. Compare rates of Grades 3&4 adverse events during treatment between subjects randomized to the two regimens. 4. Compare health system costs, and cost-effectiveness of the two regimens, in the different sites. 5. Describe occurrence of drug resistance (to INH or RIF) among subjects who develop confirmed active TB. Previous secondary outcome measures until 26/07/2012: Compare the cumulative incidence of confirmed active TB among those who took at least 80% of doses of the LTBI treatment to which they were randomised, in less than 120% of the allowed time (i.e. efficacy) | — |
Countries
Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Korea, South, Saudi Arabia
Outcome results
None listed