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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Infections, Rotavirus

Treatments

Other: Health economics questionnaire

Procedure: Collection of stool samples

Study type

Observational

Funder types

Industry

Identifiers

110436

Details and patient eligibility

About

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

Full 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

Enrollment

1,234 patients

Sex

All

Ages

Under 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.
A subject, who during the study period:
- Is hospitalised for acute gastroenteritis Or
- Visits an emergency room for acute gastroenteritis Or
- Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation

Exclusion criteria

Not applicable