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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rotavirus Gastroenteritis

Treatments: Other: Data collection; Procedure: Stool sample

Study type: Observational

Funder types: Industry

Identifiers

NCT00751686

109355

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

128 participants in 1 patient group

RV GE Group

Treatment:

Other: Data collection

Procedure: Stool sample