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

April 15, 2018 updated by: Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico

Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive HIV TST tuberculin

Exclusion Criteria:

  • Previous TB treatment Hepatic failure AIDS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Patients with a -TST
In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months
Drug: Isoniazid 300Mg Tab
-TST tests will receive isoniazid 300Mg Tab for 6 months
Other Names:
  • Isoniazid 300 mgs.
ACTIVE_COMPARATOR: 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
Drug: Isoniazid 300 MG
+ TST test will receive isoniazid 300MG Tab for 6 months
Other Names:
  • Isoniazid
Drug: Isoniazid 300 MG
HIV positive patient will receive isoniazid 300MGTab for 6 months
Other Names:
  • Isoniazid 300 mg per day
ACTIVE_COMPARATOR: 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
Drug: Isoniazid 300 MG
+ TST test will receive isoniazid 300MG Tab for 6 months
Other Names:
  • Isoniazid
Drug: Isoniazid 300 MG
HIV positive patient will receive isoniazid 300MGTab for 6 months
Other Names:
  • Isoniazid 300 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of active TB
Time Frame: 6 months
Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Salud Publica, Mexico

Investigators

  • Principal Investigator: Garcia-Garcia Lourdes, Doctor, National Institute of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 7, 2018

First Posted (ACTUAL)

April 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 15, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-543

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Isoniazid 300Mg Tab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe