Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
试验速览
- 阶段
- 不适用
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Hepatitis E virus prevalence in pediatric transplanted patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<18 years old
- •transplantation (heart, kidney, lung or bone marrow)
- •protocol acceptance by family
- •social security available
排除标准
- •protocol rejection by family
研究组 & 干预措施
Transplanted patients
All patients included are in the same arm.
干预措施: Hepatitis E serology (Biological)
结局指标
主要结局
Hepatitis E virus prevalence in pediatric transplanted patients
时间窗: 6 months
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.
次要结局
- Correlation between HEV prevalence and the different types of transplantation(6 months)
