Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden

Study Overview
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Brief Summary
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This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Official Title
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A Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE, Its Complications and Diversity of Co-circulating Rotavirus Strains in Children < 5 Years of Age in Sweden

Conditions
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Rotavirus Gastroenteritis, Infections, Rotavirus

Intervention / Treatment
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* Procedure: Blood sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from parent or guardian A male/ female child aged less than 5 years. On the day of fifth birthday the subject is not eligible for participation Hospitalised for acute GE Developed symptoms of acute GE 72 hours after hospitalisation Stool sample should be positive for the presence of rotavirus, which will be detected either by Vikia test or by ELISA Inclusion criteria for household members: Family members including care-takers and sibling staying in the same house and who spend most of the nights (50%) with the sick child. Written permission from care-takers or siblings or their parents. Exclusion Criteria: - All children in the neonatal wards.

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE. | Procedure: Blood sample collection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections |  |  | 
| To check the incidence of RV antigenemia and viremia associated with severe RV GE and relate this to clinical symptoms and rate of complications in population under surveillance. |  |  | 
| To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance. |  |  | 
| To explore the possible role of anti-secretory factor in children with RV GE and relate this to clinical symptoms and rate of complications under surveillance. |  |  | 
| To genotype the isolated rotavirus strains and evaluate a possible correlation to evolved antigenemia, liver involvement and complications in both nosocomially and community-acquired cases with infection of different strain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus gastroenteritis