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临床试验/NCT03910946
NCT03910946Unknown不适用

Prevalence of Latent Tuberculosis in High Risk Children Attending Pediatric Hospital of Assiut University

Assiut University0 个研究点目标入组 100 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
主要终点
Prevalence of Latent Tuberculosis in High Risk Young Children Attending Pediatric Hospital of Assiut University

研究概览

简要总结

identify the prevalence of latent tuberculosis (according to new guideline ;NICE tuberculosis) among these high risk groups of children and notify ministry of health

详细描述

TB is an infectious disease caused by the bacillus Mycobacterium tuberculosis. It typically affects the lungs (pulmonary TB) but can also affect other sites (extrapulmonary TB). The disease is spread when people who are sick with pulmonary TB expel bacteria into the air, for example by coughing. Overall, a relatively small proportion (5-15%) of the estimated 1.7 billion people infected with M. tuberculosis will develop TB disease (active disease) during their lifetime. However, the probability of developing TB disease is much higher among people infected with HIV, and also higher among people affected by risk factors such as under-nutrition, diabetes, smoking and alcohol consumption. Latent tuberculosis infection (LTBI) is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifest active TB. As there is no "gold standard" test for LTBI, the global burden is not known with certainty; however, up to one third of the world's population is estimated to be infected with M. tuberculosis , and the vast majority have no signs or symptoms of TB disease and are not infectious, although they are at risk for active TB disease and for becoming infectious. Several studies have shown that, on average, 5-10% of those infected will develop active TB disease over the course of their lives, usually within the first 5 years after initial infection . The risk for active TB disease after infection depends on several factors, the most important being immunological status

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged under 5 yearsold with one of the following risk factor :
  • have diabetes
  • have chronic kidney disease or receive haemodialysis

排除标准

  • All children aged above 12 years old
  • History of recent contact with TB positive patient
  • All children under 5 yearsold without any other risk factor

研究组 & 干预措施

diabetic and renal

all cases included in the study will be subjected to : Full clinical history to rule out active TB ( history of current prolonged cough, haemoptysis, fever, night sweats, weight loss, chest pain, shortness of breath, fatigue.) Chest x ray TST (tuberculin sensitivity test) : injecting a 0.1 mL of liquid containing 5 TU (tuberculin units) PPD (purified protein derivative) into the top layers of skin of the forearm and read skin tests 48-72 hours after the injection

干预措施: Tuberculin, Purified Protein 5Unt/0.1 mL Solution (Drug)

结局指标

主要结局

Prevalence of Latent Tuberculosis in High Risk Young Children Attending Pediatric Hospital of Assiut University

时间窗: one year

To identify the prevalence of latent tuberculosis (according to new guideline ;NICE tuberculosis) among these high risk groups of children and notify ministry of health

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nasef safwat lemby

doctor

Assiut University

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