Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis

Study Overview
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Brief Summary
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Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts. Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).

Official Title
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Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population

Conditions
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Latent Tuberculosis, Diabetes Mellitus

Intervention / Treatment
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* Drug: Isoniazid 300Mg Tab
* Drug: Isoniazid 300 MG
* Drug: Isoniazid 300 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive HIV TST tuberculin Exclusion Criteria: Previous TB treatment Hepatic failure AIDS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with a -TST<br>In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months | Drug: Isoniazid 300Mg Tab<br>* -TST tests will receive isoniazid 300Mg Tab for 6 months<br>* Other names: Isoniazid 300 mgs.;|
| Active Comparator: Patients with a +TST<br>In patients with a +TST test researchers will test for HIV, hepatic function and we will take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months | Drug: Isoniazid 300 MG<br>* + TST test will receive isoniazid 300MG Tab for 6 months<br>* Other names: Isoniazid;|
| Active Comparator: HIV positive patients<br>The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months | Drug: Isoniazid 300 MG<br>* HIV positive patient will receive isoniazid 300MGTab for 6 months<br>* Other names: Isoniazid 300 mg per day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of active TB | Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, Latent infection, Tuberculosis, Interferon gamma