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

NCT03498534 | Withdrawn Phase 4 DMC

• 1 other identifier: CI-543
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Latent Tuberculosis; Diabetes Mellitus

Keywords

Treatment; Latent infection; Tuberculosis; Interferon gamma

Outcome Measures

Primary Outcomes (1)

• Development of active TB

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

  6 months

Study Arms (3)

Patients with a -TST

ACTIVE COMPARATOR

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

Drug: Isoniazid 300Mg Tab

Patients with a +TST

ACTIVE COMPARATOR

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

HIV positive patients

ACTIVE COMPARATOR

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

Interventions

Isoniazid 300Mg Tab DRUG

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

Also known as: Isoniazid 300 mgs.

Patients with a -TST

Isoniazid 300 MG DRUG

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

Also known as: Isoniazid

Patients with a +TST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive HIV TST tuberculin

You may not qualify if:

• Previous TB treatment Hepatic failure AIDS

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead

MeSH Terms

Conditions

Latent Tuberculosis; Diabetes Mellitus; Latent Infection; Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Garcia-Garcia Lourdes, Doctor

  National Institute of public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center of Research in Infectious Diseases

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 13, 2018
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 17, 2018

Record last verified: 2018-04