Diagnosis of Tuberculosis Infection in HIV Co-infected Children (ThrasherIGRA)
Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival.
The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited.
Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children:
- assess the agreement between the TST and blood-based diagnostic testing,
- compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
- measure the impact of age, nutritional and immune status on children's response to blood-based testing,
- describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB.
Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Western Cape
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Tygerberg、Western Cape、南非、07505
- Despond TuTu TB Centre, Stellenbosch University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- age less than 15 years
- completion of informed consent
Exclusion Criteria:
- less than 3 months of age
- documented anemia
- recent diagnosis of tuberculosis
- receiving treatment for tuberculosis
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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B
M.tb unexposed HIV-infected and uninfected children <15 years of age
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A
M.tb exposed HIV-infected and uninfected children <15 years of age
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合作者和调查者
调查人员
- 首席研究员:Anna M Mandalakas, MD, PhD、Baylor College of Medicine
- 首席研究员:Anneke C Hesseling, MD, MS、University of Stellenbosch
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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