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

Rotaviral Gastroenteritis Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201252
• Other study ID #: 110846
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: November 15, 2012
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Rotaviral Gastroenteritis

Intervention

Procedure:
• Stool sampling
Stool samples will be collected, tested and genotyped for the presence of rotavirus

Locations

Country	Name	City	State
United Arab Emirates	GSK Investigational Site	Abu-Dhabi
United Arab Emirates	GSK Investigational Site	Al-Ain
United Arab Emirates	GSK Investigational Site	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.		Twelve months from study initiation	No
Secondary	Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.		Twelve months from study initiation	No
Secondary	Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.		Twelve months from study initiation	No
Secondary	Distribution of different strains of rotavirus in children < 5 years of age.		Twelve months from study initiation	No
Secondary	Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.		Twelve months from study initiation	No
Secondary	Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.		Twelve months from study initiation	No