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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01201252
First received: September 13, 2010
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Rotaviral Gastroenteritis
 Procedure: Stool sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus. [ Time Frame: Twelve months from study initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age. [ Time Frame: Twelve months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis. [ Time Frame: Twelve months from study initiation ] [ Designated as safety issue: No ]
  • Distribution of different strains of rotavirus in children < 5 years of age. [ Time Frame: Twelve months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age. [ Time Frame: Twelve months from study initiation ] [ Designated as safety issue: No ]
  • Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age. [ Time Frame: Twelve months from study initiation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stool


Enrollment: 717
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute gastroenteritis Group
Suspected/confirmed cases of rotavirus gastroenteritis in children < 5 years of age
 Procedure: Stool sampling
Stool samples will be collected, tested and genotyped for the presence of rotavirus

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children < 5 years of age hospitalised with acute gastroenteritis

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201252

Locations
United Arab Emirates
GSK Investigational Site
Abu-Dhabi, United Arab Emirates
GSK Investigational Site
Al-Ain, United Arab Emirates
GSK Investigational Site
Sharjah, United Arab Emirates
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01201252     History of Changes
Other Study ID Numbers: 110846
Study First Received: September 13, 2010
Last Updated: November 15, 2012
Health Authority: United Arab Emirates: Ministry of Health

Keywords provided by GlaxoSmithKline:
children
gastroenteritis
Rotavirus

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013