Rifampin versus isoniazid for the treatment of latent tuberculosis infection: Part 3 effectiveness

Not Applicable

Completed

• Conditions: atent tuberculosis infection; Infections and Infestations; Tuberculosis

• Registration Number: ISRCTN05675547
• Lead Sponsor: The Research Institute of the McGill University Health Centre (Canada)

Brief Summary

1. 2008 adverse events results in: http://www.ncbi.nlm.nih.gov/pubmed/19017587 2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30067931 (added 22/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-29
• Study Completion: 2016-03-31
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5720

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified