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

April 9, 2015 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 021105
        • GSK Investigational Site
      • Bucharest, Romania
        • GSK Investigational Site
      • Cluj, Romania, 400348
        • GSK Investigational Site
      • Cluj Napoca, Romania
        • GSK Investigational Site
      • Constanta, Romania, 900708
        • GSK Investigational Site
      • Craiova, Romania
        • GSK Investigational Site
      • Sibiu, Romania
        • GSK Investigational Site
      • Timisoara, Romania
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children < 5 years of age treated at a hospital site (subjects hospitalised with community acquired acute gastroenteritis, subjects who visited the emergency room for acute gastroenteritis or subjects with medical care associated rotavirus infection).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Subjects who are hospitalised for acute gastroenteritis
Procedure: Collection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Other: Health economics questionnaire
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
Procedure: Collection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Other: Health economics questionnaire
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.
Procedure: Collection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Other: Health economics questionnaire
For a subset of subjects, additional economic data will be gathered by completing a questionnaire

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110436

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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