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临床试验/NCT03028129
NCT03028129终止4 期

Primary Prophylaxis for Prevention of TB in Prison's Populations

Federal University of Mato Grosso1 个研究点 分布在 1 个国家目标入组 467 人开始时间: 2017年9月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
467
试验地点
1
主要终点
Quantiferon TB Gold Plus (QIAGEN®) Conversion at the Premature Exclusion Visit.

研究概览

简要总结

The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.

详细描述

Despite being a known disease of mankind over 9000 years, tuberculosis (TB) is still a major public health problem in developing countries, mainly due to so-called highly endemic sites, such as prisons.

It is Infectious disease, with airborne transmission, TB can present both the active or latent form. Despite the biological aspect of transmission, unhealthy environmental conditions (room without direct sunlight, poor ventilation and overcrowded) and individual factors (malnutrition, immunosuppression, use of alcohol and other drugs) have significant influence on transferability and infectivity.

With the discovery of drugs active against Mycobacterium tuberculosis, it was observed a reduction of disease incidence in the world. Despite this declining incidence, World Health Organization (WHO) classifies TB as a public health problem due to the emergence of multidrug strains or extensively resistant to treatment, added to the cases of latent TB reactivation, observed with the advent of HIV/AIDS.

Studies show a direct relationship between the incidence of TB and the prison environment. Nevertheless, the presence of prisons in one location increases the incidence of this disease, indicating that there is an exchange of disease between the prison and the community.

Currently, control of TB in the prison system is based on the tracking of individuals with active TB and / or latent and, in their respective treatment. For the identification of individuals with active disease, it is necessary the recognition of respiratory symptoms (cough mainly) and sputum smear microscopy and sputum culture, and chest X-ray. As the search of individuals with latent form, must be carried to the skin test with Purified Protein Derived (PPD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Treatment

Experimental

Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.

干预措施: Isoniazid 900 milligrams (Drug)

Control

Placebo Comparator

Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).

干预措施: Placebo (Drug)

结局指标

主要结局

Quantiferon TB Gold Plus (QIAGEN®) Conversion at the Premature Exclusion Visit.

时间窗: up to 6 months

Number of participants who had a Quantiferon TB Gold Plus (QIAGEN®) score greater than or equal to 0.35 international units per milliliter, at the time of the premature exclusion visit, on all participants in the group.

次要结局

未报告次要终点

研究者

发起方
Federal University of Mato Grosso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto D Oliveira

PhD Student

Federal University of Mato Grosso

研究点 (1)

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