NCT01253967

Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,234 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \< 5 years of age in Romania.

Detailed description

The study consist of a main study and a health economics study Main study: The study will focus on three different groups of patients: * Subjects who are hospitalised for acute gastroenteritis. * Subjects who visit an emergency room for acute gastroenteritis. * Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation. Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
PROCEDURE	Collection of stool samples	Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
OTHER	Health economics questionnaire	For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2010-12-06
• Last updated: 2015-04-13

Locations

8 sites across 1 country: Romania