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

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



Sponsors


Source

Instituto Nacional de Salud Publica, Mexico

Oversight Info

Has Dmc

Yes


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).

Overall Status

Withdrawn

Start Date

2012-09-01

Completion Date

2013-12-01

Primary Completion Date

2012-12-01

Phase

Phase 4

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Development of active TB
6 months

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Patients with a -TST

Other Name

Isoniazid 300 mgs.


Intervention Type

Drug

Intervention Name


Description

+ TST test will receive isoniazid 300MG Tab for 6 months
TEST(PROOF) D HEPATIC EFUNCION AND X-RAY PHOTOGRAPHY OF NORMAL THORAX, THEY WILL TAKE TREATMENT WITH 300 ISONIACIDA's MG

Arm Group Label

Patients with a +TST

Other Name

Isoniazid


Intervention Type

Drug

Intervention Name


Description

HIV positive patient will receive isoniazid 300MGTab for 6 months

Arm Group Label

HIV positive patients

Other Name

Isoniazid 300 mg per day



Eligibility

Criteria

Inclusion Criteria:

- Positive IHV TST tuberculin

Exclusion Criteria:

- Previous TB treatment Danger hepatic SIDA

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Garcia-Garcia Lourdes, Doctor
Principal Investigator
National Institute of public Health

Verification Date

2018-04-01

Lastchanged Date

2018-04-07

Firstreceived Date

2012-03-28

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Instituto Nacional de Salud Publica, Mexico

Investigator Full Name

Ma. de Lourdes Garcia Garcia

Investigator Title

Director of the Center of Research in Infectious Diseases


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Intervention Browse

Mesh Term

Isoniazid


Arm Group

Arm Group Label

Patients with a -TST

Arm Group Type

Active Comparator

Description

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


Arm Group Label

Patients with a +TST

Arm Group Type

Active Comparator

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 Group Label

HIV positive patients

Arm Group Type

Active Comparator

Description

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



Firstreceived Results Date

N/A

Why Stopped

Due to administrative procedures

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Single Group Assignment

Primary Purpose

Prevention

Masking

None (Open Label)


Study First Submitted

March 28, 2012

Study First Submitted Qc

April 7, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 7, 2018

Last Update Submitted Qc

April 7, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on April 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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