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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498534
Enrollment
0
Registered
2018-04-13
Start date
2012-09-30
Completion date
2013-12-31
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Latent Tuberculosis

Keywords

Treatment, Latent infection, Tuberculosis, Interferon gamma

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).

Interventions

DRUGIsoniazid 300Mg Tab

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

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

Sponsors

Instituto Nacional de Salud Publica, Mexico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Positive HIV TST tuberculin

Exclusion criteria

* Previous TB treatment Hepatic failure AIDS

Design outcomes

Primary

MeasureTime frameDescription
Development of active TB6 monthsResearchers will test patients at day 0 and day 180 of treatment to detect the development of active TB

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026