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

Phase 4

Withdrawn

• Conditions: Latent Tuberculosis; Diabetes Mellitus
• Interventions: Drug: Isoniazid 300Mg Tab; Drug: Isoniazid 300 MG

• Registration Number: NCT03498534
• Lead Sponsor: Instituto Nacional de Salud Publica, Mexico

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-28
• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-07
• Study First Posted: 2018-04-13
• Last Update Submitted: 2018-04-15
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Positive HIV TST tuberculin

Exclusion Criteria

• Previous TB treatment Hepatic failure AIDS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with a -TST	Isoniazid 300Mg Tab	In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months
Patients with a +TST	Isoniazid 300 MG	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
HIV positive patients	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

Primary Outcome Measures

Name	Time	Method
Development of active TB	6 months	Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB