Status:
COMPLETED
Randomized Clinical Trial Comparing 4RIF vs. 9INH for LTBI Treatment-effectiveness
Lead Sponsor:
McGill University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Latent Tuberculosis Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
On a global scale, tuberculosis (TB) is the single most important infectious cause of morbidity and mortality. The World Health Organization has estimated that one-third of the entire world's populati...
Detailed Description
On a global scale, tuberculosis (TB) is the single most important infectious cause of morbidity and mortality. The World Health Organization has estimated that one-third of the entire world's populati...
Eligibility Criteria
Inclusion
- Adult (age 18 years and older) with documented positive TST (or in the absence of TST, a documented positive QFT) and prescribed 9 months of Isoniazid for LTBI, following authoritative recommendations.
Exclusion
- Patients who were contacts of TB cases known to be resistant to Isoniazid, Rifampin, or both.
- Known 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.
- Pregnant women - Rifampin and Isoniazid are considered safe in pregnancy but therapy is usually deferred until 2-3 months post-partum to avoid fetal risk and the potential for increased hepato-toxicity immediately post partum.
- Patients on any medication with clinically important drug interactions with Isoniazid or Rifampin, which their physician believes would make either arm contra-indicated.
- Patients with a history of allergy/hypersensitivity to Isoniazid or to Rifampin, Rifabutin or Rifapentine.
- Patients with active TB. Patients initially suspected to have active TB can be randomized once this has been excluded.
- Patients who have already started LTBI therapy.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
6031 Patients enrolled
Trial Details
Trial ID
NCT00931736
Start Date
August 1 2009
End Date
April 1 2017
Last Update
December 19 2017
Active Locations (12)
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1
Woolcock Institute of Medical Research
Sydney, New South Wales, Australia
2
Centre de Pneumophthysiologie
Cotonou, Benin
3
Universidade Gama Filho, Centro de Ciências Biológicas e da Saúde
Rio de Janeiro, Brazil
4
University of Alberta
Edmonton, Alberta, Canada