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

NCT01201252 | Completed

• 1 other identifier: 110846
• Study Type: observational
• Target: 717
• Locations: 1 country
• Sites: 3

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.

Conditions

Rotaviral Gastroenteritis

Keywords

children; gastroenteritis; Rotavirus

Outcome Measures

Primary Outcomes (1)

• Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.

  Twelve months from study initiation

Secondary Outcomes (5)

• Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.

  Twelve months from study initiation

• Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.

  Twelve months from study initiation

• Distribution of different strains of rotavirus in children < 5 years of age.

  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

• Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.

  Twelve months from study initiation

Study Arms (1)

Acute gastroenteritis Group

Suspected/confirmed cases of rotavirus gastroenteritis in children \< 5 years of age

Procedure: Stool sampling

Interventions

Stool sampling PROCEDURE

Stool samples will be collected, tested and genotyped for the presence of rotavirus

Acute gastroenteritis Group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children \< 5 years of age hospitalised with acute gastroenteritis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Abu Dhabi, United Arab Emirates

Location

GSK Investigational Site

Al Ain City, United Arab Emirates

Location

GSK Investigational Site

Sharjah city, United Arab Emirates

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

AE (3)