Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece

GlaxoSmithKline128 enrolled

Overview

The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Rotavirus Gastroenteritis

Interventions

Stool samplePROCEDURE

Collection of the stool at least 48 hours after hospitalisation. Stool samples should be obtained preferably within 4 and no later than 10 days after the onset of the GE symptoms.

Data collectionOTHER

Logbook, Health Economic Questionnaire, Telephone call.

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female child \< 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday). * Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation. * Written informed consent obtained from the parent/guardian of the subject. * Children with RV positive stool sample will be enrolled in the study. Exclusion Criteria: • Not applicable.

Locations (6)

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Heraklion, Crete, Greece

GSK Investigational Site

Rio/Patras, Greece

Outcomes

Primary Outcomes

Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.