Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates

November 15, 2012 updated by: GlaxoSmithKline

An Observational, Hospital-based Surveillance to Estimate the Disease Burden of Acute Rotavirus (RV) Gastroenteritis (GE) in Children < 5 Years of Age in United Arab Emirates (UAE).

The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

717

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

  • United Arab Emirates
      • Abu-Dhabi, United Arab Emirates
        • GSK Investigational Site
      • Al-Ain, United Arab Emirates
        • GSK Investigational Site
      • Sharjah, United Arab Emirates
        • 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 hospitalised with acute gastroenteritis

Description

Inclusion Criteria:

  • A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
  • Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

  • The diagnosis for treatment at the study site does not include acute gastroenteritis.
  • The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute gastroenteritis Group
Suspected/confirmed cases of rotavirus gastroenteritis in children < 5 years of age
Procedure: Stool sampling
Stool samples will be collected, tested and genotyped for the presence of rotavirus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.
Time Frame: Twelve months from study initiation
Twelve months from study initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.
Time Frame: Twelve months from study initiation
Twelve months from study initiation
Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.
Time Frame: Twelve months from study initiation
Twelve months from study initiation
Distribution of different strains of rotavirus in children < 5 years of age.
Time Frame: Twelve months from study initiation
Twelve months from study initiation
Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.
Time Frame: Twelve months from study initiation
Twelve months from study initiation
Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.
Time Frame: Twelve months from study initiation
Twelve months from study initiation

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

July 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110846

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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