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

Completed

• Conditions: Rotaviral Gastroenteritis
• Interventions: Procedure: Stool sampling

• Registration Number: NCT01201252
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 717

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute gastroenteritis Group	Stool sampling	Suspected/confirmed cases of rotavirus gastroenteritis in children \< 5 years of age

Primary Outcome Measures

Name	Time	Method
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.	Twelve months from study initiation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇪 Sharjah, United Arab Emirates