HEV: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transplanted patients All patients included are in the same arm. |
Biological: Hepatitis E serology
|
Outcome Measures
Primary Outcome Measures
- Hepatitis E virus prevalence in pediatric transplanted patients [Day 1]
- Hepatitis E virus prevalence in pediatric transplanted patients [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.
Secondary Outcome Measures
- Correlation between HEV prevalence and the different types of transplantation [Day 1]
- Correlation between HEV prevalence and the different types of transplantation [6 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospices Civils de Lyon | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-810