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临床试验/NCT03498534
NCT03498534撤回4 期

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

Instituto Nacional de Salud Publica, Mexico0 个研究点开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
主要终点
Development of active TB

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Positive HIV TST tuberculin

排除标准

  • Previous TB treatment Hepatic failure AIDS

研究组 & 干预措施

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

干预措施: Isoniazid 300Mg Tab (Drug)

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

干预措施: Isoniazid 300 MG (Drug)

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

干预措施: Isoniazid 300 MG (Drug)

结局指标

主要结局

Development of active TB

时间窗: 6 months

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

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Salud Publica, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ma. de Lourdes Garcia Garcia

Director of the Center of Research in Infectious Diseases

Instituto Nacional de Salud Publica, Mexico

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