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

Primary Purpose

Latent Tuberculosis, Diabetes Mellitus

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Isoniazid 300Mg Tab

Isoniazid 300 MG

About this trial

This is an interventional prevention trial for Latent Tuberculosis focused on measuring Treatment, Latent infection, Tuberculosis, Interferon gamma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive HIV TST tuberculin

Exclusion Criteria:

Previous TB treatment Hepatic failure AIDS

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Patients with a -TST

Patients with a +TST

HIV positive patients

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Development of active TB

Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB

Secondary Outcome Measures

Full Information

NCT ID

NCT03498534

First Posted

March 28, 2012

Last Updated

April 15, 2018

Sponsor

Instituto Nacional de Salud Publica, Mexico

1. Study Identification

Unique Protocol Identification Number

NCT03498534

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Due to administrative procedures

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Salud Publica, Mexico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Latent Tuberculosis, Diabetes Mellitus

Keywords

Treatment, Latent infection, Tuberculosis, Interferon gamma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with a -TST

Arm Type

Active Comparator

Arm Description

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

Arm Title

Patients with a +TST

Arm Type

Active Comparator

Arm Description

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

Arm Title

HIV positive patients

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Isoniazid 300Mg Tab

Other Intervention Name(s)

Isoniazid 300 mgs.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Isoniazid 300 MG

Other Intervention Name(s)

Isoniazid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Isoniazid 300 MG

Other Intervention Name(s)

Isoniazid 300 mg per day

Intervention Description

HIV positive patient will receive isoniazid 300MGTab for 6 months

Primary Outcome Measure Information:

Title

Development of active TB

Description

Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Positive HIV TST tuberculin Exclusion Criteria: Previous TB treatment Hepatic failure AIDS

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Garcia-Garcia Lourdes, Doctor

Organizational Affiliation

National Institute of public Health

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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