A Phase 4 interventional study of Isoniazid 300Mg Tab and Isoniazid 300 MG in Latent Tuberculosis and Diabetes Mellitus, sponsored by Instituto Nacional de Salud Publica, Mexico. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Instituto Nacional de Salud Publica, Mexico · Phase 4, Interventional, and Prevention
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).
Exclusion Criteria:
In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months
Drug: Isoniazid 300Mg Tab
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
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
-TST tests will receive isoniazid 300Mg Tab for 6 months
Also known as: Isoniazid 300 mgs.
+ TST test will receive isoniazid 300MG Tab for 6 months
Also known as: Isoniazid
HIV positive patient will receive isoniazid 300MGTab for 6 months
Also known as: Isoniazid 300 mg per day
Development of active TB
Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB
Time frame: 6 months
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Salud Publica, Mexico