Overview

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

Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto Nacional de Salud Publica, Mexico
Treatments:
Isoniazid
Criteria
Inclusion Criteria:

- Positive HIV TST tuberculin

Exclusion Criteria:

- Previous TB treatment Hepatic failure AIDS