Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population
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
- 否
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
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
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
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
Ma. de Lourdes Garcia Garcia
Director of the Center of Research in Infectious Diseases
Instituto Nacional de Salud Publica, Mexico
