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

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).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01201252
Enrollment
717
Registered
2010-09-14
Start date
2009-07-31
Completion date
2010-07-31
Last updated
2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotaviral Gastroenteritis

Keywords

children, gastroenteritis, Rotavirus

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.

Interventions

PROCEDUREStool sampling

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

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among 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 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

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026