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

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

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-03-31

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.

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Detailed Description

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Conditions

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Rotavirus Gastroenteritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RV GE Group

Stool sample

Intervention Type PROCEDURE

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.

Data collection

Intervention Type OTHER

Logbook, Health Economic Questionnaire, Telephone call.

Interventions

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Stool sample

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.

Intervention Type PROCEDURE

Data collection

Logbook, Health Economic Questionnaire, Telephone call.

Intervention Type OTHER

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.