NCT03498534

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• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Instituto Nacional de Salud Publica, Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Isoniazid 300Mg Tab	-TST tests will receive isoniazid 300Mg Tab for 6 months
DRUG	Isoniazid 300 MG	\+ TST test will receive isoniazid 300MG Tab for 6 months
DRUG	Isoniazid 300 MG	HIV positive patient will receive isoniazid 300MGTab for 6 months

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2018-04-13
• Last updated: 2018-04-17