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

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

Detailed Description
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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

Official Title
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Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Procedure: Collection of stool samples
* Other: Health economics questionnaire


Participation Criteria
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Eligibility Criteria
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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

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 |
| --- | --- |
| Group A<br>Subjects who are hospitalised for acute gastroenteritis | Procedure: Collection of stool samples<br>* Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.<br>Other: Health economics questionnaire<br>* For a subset of subjects, additional economic data will be gathered by completing a questionnaire<br>|
| Group B<br>Subjects who visit an emergency room for acute gastroenteritis | Procedure: Collection of stool samples<br>* Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.<br>Other: Health economics questionnaire<br>* For a subset of subjects, additional economic data will be gathered by completing a questionnaire<br>|
| Group C<br>Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation. | Procedure: Collection of stool samples<br>* Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.<br>Other: Health economics questionnaire<br>* For a subset of subjects, additional economic data will be gathered by completing a questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age |  | At least 12 months from study start | 
| Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age |  | At least 12 months from study start | 
| Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age |  | At least 12 months from study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age distribution of children with rotavirus gastroenteritis |  | At least 12 months from study start | 
| Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age |  | At least 12 months from study start | 
| Potential risk factors for rotavirus gastroenteritis |  | At least 12 months from study start | 
| Rotavirus gastroenteritis associated costs |  | At least 12 months from study start | 
| Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age |  | At least 12 months from study start | 
| Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age |  | At least 12 months from study start | 
| Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age |  | At least 12 months from study start | 
| Severity of rotavirus among all children < 5 years of age |  | At least 12 months from study | 
| Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age |  | At least 12 months from study start | 
| Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age |  | At least 12 months from study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenteritis, Hospital surveillance, Rotavirus gastroenteritis