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Completed

NCT Number: NCT01201252

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

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.

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Key information

Conditions

Rotaviral Gastroenteritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Abu Dhabi, United Arab Emirates

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stool sampling

Procedure

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

Primary outcomes

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

    Time frame: Twelve months from study initiation

Secondary outcomes

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

    Time frame: Twelve months from study initiation

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

    Time frame: Twelve months from study initiation

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

    Time frame: Twelve months from study initiation

  4. Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.

    Time frame: Twelve months from study initiation

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

    Time frame: Twelve months from study initiation

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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).

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2010
Registry last updated
Nov 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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