Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study (HEV)
Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype found in Europe and North America and is responsible for sporadic infections except for travel associated diseases.
HEV had a principally asymptomatic form. However, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack of information about the prevalence of this disease.
In Canada the incidence of HEV infection was high (15-86% for liver transplanted children with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney transplanted children whereas 7,4% in control. It was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.
This study will determined in a prospective approach the HEV prevalence in kidney, lung, heart and bone marrow transplanted children in Lyon.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Noémie Laverdure, MD
- 电话号码:+33 698166674
- 邮箱:noemie.laverdure@free.fr
研究联系人备份
- 姓名:Alain LACHAUX, MD
学习地点
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Bron、法国、69500
- 招聘中
- Hospices Civils de Lyon
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接触:
- Noémie Laverdure, MD
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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
描述
Inclusion Criteria:
- <18 years old
- transplantation (heart, kidney, lung or bone marrow)
- protocol acceptance by family
- social security available
Exclusion Criteria:
- protocol rejection by family
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Transplanted patients
All patients included are in the same arm.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Hepatitis E virus prevalence in pediatric transplanted patients
大体时间:Day 1
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Day 1
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Hepatitis E virus prevalence in pediatric transplanted patients
大体时间:6 months
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Hepatitis E virus (HEV) serology : IgG & IgM, and PCR HEV.
If serology is positive a second serology will be performed 6 months after in order to detect chronic infection.
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6 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
Correlation between HEV prevalence and the different types of transplantation
大体时间:Day 1
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Day 1
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Correlation between HEV prevalence and the different types of transplantation
大体时间:6 months
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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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