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

NCT ID: NCT03498534

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

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).

Detailed Description

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Conditions

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Latent Tuberculosis Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients with a -TST

In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months

Group Type ACTIVE_COMPARATOR

Isoniazid 300Mg Tab

Intervention Type DRUG

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

Patients with a +TST

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

Group Type ACTIVE_COMPARATOR

Isoniazid 300 MG

Intervention Type DRUG

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

HIV positive patients

The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months

Group Type ACTIVE_COMPARATOR

Isoniazid 300 MG

Intervention Type DRUG

HIV positive patient will receive isoniazid 300MGTab for 6 months

Interventions

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Isoniazid 300Mg Tab

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

Intervention Type DRUG

Isoniazid 300 MG

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

Intervention Type DRUG

Isoniazid 300 MG

HIV positive patient will receive isoniazid 300MGTab for 6 months

Intervention Type DRUG

Other Intervention Names

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Isoniazid 300 mgs. Isoniazid Isoniazid 300 mg per day

Eligibility Criteria

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Inclusion Criteria

* Positive HIV TST tuberculin

Exclusion Criteria

* Previous TB treatment Hepatic failure AIDS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role lead

Responsible Party

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Ma. de Lourdes Garcia Garcia

Director of the Center of Research in Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Garcia-Garcia Lourdes, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Institute of public Health

Other Identifiers

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CI-543

Identifier Type: -

Identifier Source: org_study_id

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