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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rotaviral Gastroenteritis

Treatments: Procedure: Stool sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT01201252

110846

Details and patient eligibility

About

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.

Enrollment: 717 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

717 participants in 1 patient group

Acute gastroenteritis Group

Description:

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

Treatment:

Procedure: Stool sampling