Status:
COMPLETED
Rifampin Versus Isoniazid for the Treatment of Latent Tuberculosis Infection in Children (P4v9)
Lead Sponsor:
McGill University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Latent Tuberculosis Infection
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to children, especially those living in the same household. Once children are exposed and infected they are a...
Detailed Description
On a global scale tuberculosis (TB) is the single most important infectious cause of morbidity and mortality in individuals aged 15-49. The World Health Organization has estimated that one third of th...
Eligibility Criteria
Inclusion
- Children (age \<18) with documented positive TST (or in the absence of TST, a positive QFT or T-Spot) and prescribed 9INH for LTBI for the following indications:
- HIV positive (TST \>5 mm or QFT+)
- Age 5 or less (TST \>5 mm or QFT+)
- Other reason for immuno-compromised state - such as therapy for malignancy or post-transplant (TST \>5 mm or QFT+)
- Contact: with adult or adolescent with active contagious pulmonary TB. (TST \>5 mm or QFT +)
- Have both of the following factors if TST = 10-14mm or QFT + or one factor if TST \>15mm :
- Arrival in Canada, Australia, or Saudi Arabia in the past 2 years from countries with estimated annual incidence of active TB greater than 100 per 100,000
- Body mass index (BMI) less than 10th percentile for their age
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.
- Prior complete LTBI therapy or if children have taken \>1 week and are still taking the treatment. Children will be eligible if they took an incomplete LTBI therapy (less than 80% of recommended total dose) but \> 6 months ago.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
844 Patients enrolled
Trial Details
Trial ID
NCT00170209
Start Date
August 1 2011
End Date
May 1 2015
Last Update
December 19 2017
Active Locations (9)
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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