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

NCT ID: NCT01201252

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

717 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rotaviral Gastroenteritis

Keywords

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children gastroenteritis Rotavirus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute gastroenteritis Group

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

Stool sampling

Intervention Type PROCEDURE

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

Interventions

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Stool sampling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Abu Dhabi, , United Arab Emirates

Site Status

GSK Investigational Site

Al Ain City, , United Arab Emirates

Site Status

GSK Investigational Site

Sharjah city, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Other Identifiers

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110846

Identifier Type: -

Identifier Source: org_study_id