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

Secretariat of Health

Status and phase: Withdrawn; Phase 4

Conditions: Diabetes Mellitus; Latent Tuberculosis

Treatments: Drug: Isoniazid 300 MG; Drug: Isoniazid 300Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03498534

CI-543

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive HIV TST tuberculin

Exclusion criteria

• Previous TB treatment Hepatic failure AIDS

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Patients with a -TST

Active Comparator group

Description:

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

Treatment:

Drug: Isoniazid 300Mg Tab

Patients with a +TST

Active Comparator group

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

Treatment:

Drug: Isoniazid 300 MG

Drug: Isoniazid 300 MG

HIV positive patients

Active Comparator group

Description:

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

Treatment:

Drug: Isoniazid 300 MG

Drug: Isoniazid 300 MG