Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

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.

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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

Conditions

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Infections, Rotavirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Subjects who are hospitalised for acute gastroenteritis

Collection of stool samples

Intervention Type PROCEDURE

Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

Health economics questionnaire

Intervention Type OTHER

For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Group B

Subjects who visit an emergency room for acute gastroenteritis

Collection of stool samples

Intervention Type PROCEDURE

Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

Health economics questionnaire

Intervention Type OTHER

For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Group C

Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

Collection of stool samples

Intervention Type PROCEDURE

Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

Health economics questionnaire

Intervention Type OTHER

For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Interventions

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Collection of stool samples

Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

Intervention Type PROCEDURE

Health economics questionnaire

For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Intervention Type OTHER

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