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

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ClinicalTrials.gov Identifier: NCT03498534
Recruitment Status : Withdrawn (Due to administrative procedures)
First Posted : April 13, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico

Study Description
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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).


Condition or disease Intervention/treatment Phase
Latent Tuberculosis Diabetes Mellitus Drug: Isoniazid 300Mg Tab Drug: Isoniazid 300 MG Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population
Study Start Date : September 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Isoniazid

Arms and Interventions
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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 Name: 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 Name: Isoniazid
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
HIV positive patient will receive isoniazid 300MGTab for 6 months
Other Name: Isoniazid 300 mg per day


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive HIV TST tuberculin

Exclusion Criteria:

  • Previous TB treatment Hepatic failure AIDS
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498534


Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Investigators
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Principal Investigator: Garcia-Garcia Lourdes, Doctor National Institute of public Health
More Information
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Responsible Party: Ma. de Lourdes Garcia Garcia, Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT03498534    
Other Study ID Numbers: CI-543
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Keywords provided by Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico:
Treatment
Latent infection
Tuberculosis
Interferon gamma
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents