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

NCT03498534 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-04-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Isoniazid 300Mg Tab

-TST tests will receive isoniazid 300Mg Tab for 6 months

DRUG

Isoniazid 300 MG

\+ TST test will receive isoniazid 300MG Tab for 6 months

DRUG

Isoniazid 300 MG

HIV positive patient will receive isoniazid 300MGTab for 6 months

Sponsors & Collaborators

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Garcia-Garcia Lourdes, Doctor · National Institute of public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2013-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03498534 on ClinicalTrials.gov