Status:
COMPLETED
Treatment of Latent Tuberculosis Infection With Isoniazid
Lead Sponsor:
Instituto Nacional de Salud Publica, Mexico
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Wellcome Trust
Conditions:
Tuberculosis
Eligibility:
All Genders
10-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to study the effect that treatment of dormant tuberculosis infection has on the immunological system. We expect to observe an impact over the production of cytokines by p...
Detailed Description
As part of on-going studies conducted in the Orizaba Health Jurisdiction in southeastern Mexico, household contacts of pulmonary TB patients who recently converted their tuberculin test and TST+ve con...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Informed consent
- Age 10-45
- Either sex
- Resident in study area
- Documented TST+ve (\>10mm, Mantoux method, 2TU, PPD Statens Serum Institute)
- Normal chest radiograph
- HIV negative test
- Exclusion criteria:
- Active tuberculosis
- Previous diagnosis of tuberculosis
- Treatment for active or latent tuberculosis
- Contact with TB patients harboring MDR or INH resistant isolates of Mtb
- Diseases or therapies associated with immunosuppression
- Diabetes mellitus
- Abnormal liver enzyme levels.
- HB below 8gr/dl
- Pregnancy (ascertained by urinary β-HCG)
- Allergy or intolerance to isoniazid
- Peripheral neuropathy
- Ingestion of drugs interacting with isoniazid
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00293228
Start Date
February 1 2007
End Date
June 1 2009
Last Update
May 26 2010
Active Locations (1)
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1
Instituto Nacional de Salud Pública
Cuernavaca, Morelos, Mexico, 62508