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

Completed

• Conditions: Rotavirus Gastroenteritis
• Interventions: Procedure: Stool sample; Other: Data collection

• Registration Number: NCT00751686
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RV GE Group	Data collection	-
RV GE Group	Stool sample	-

Primary Outcome Measures

Name	Time	Method
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.	Approximately 12 months
Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.	Approximately 12 months
Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.	Approximately 12 months

Secondary Outcome Measures

Name	Time	Method
Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.	Approximately 12 months
Identification of prevalent genotypes of RV among children <5 years of age.	Approximately 12 months
Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff.	Approximately 12 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇷 Thessaloniki, Greece