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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rotavirus Gastroenteritis; Infections, Rotavirus

Treatments: Procedure: Blood sample collection

Study type: Observational

Funder types: Industry

Identifiers

NCT00489567

109551

Details and patient eligibility

About

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.

Enrollment: 642 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

642 participants in 1 patient group

Group A

Description:

Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE.

Treatment:

Procedure: Blood sample collection