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

Completed

• Conditions: Rotavirus Gastroenteritis; Infections, Rotavirus
• Interventions: Procedure: Blood sample collection

• Registration Number: NCT00489567
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Study Start: 2007-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Blood sample collection	Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE.

Primary Outcome Measures

Name	Time	Method
To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.

Secondary Outcome Measures

Name	Time	Method
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