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

Study Overview
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Brief Summary
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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.

Official Title
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To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece

Conditions
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Rotavirus Gastroenteritis

Intervention / Treatment
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* Procedure: Stool sample
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RV GE Group<br> | Procedure: Stool sample<br>* 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.<br>Other: Data collection<br>* Logbook, Health Economic Questionnaire, Telephone call.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Identification of prevalent genotypes of RV among children <5 years of age. |  | Approximately 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenteritis, Rotavirus, < 5 years, Greece, Children, Burden