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Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden

NCT ID: NCT00489567

Last Updated: 2011-01-31

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

642 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

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Conditions

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Rotavirus Gastroenteritis Infections, Rotavirus

Keywords

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Rotavirus gastroenteritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE.

Blood sample collection

Intervention Type PROCEDURE

Interventions

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Blood sample collection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained from parent or guardian
* A male/ female child aged less than 5 years. On the day of fifth birthday the subject is not eligible for participation
* Hospitalised for acute GE
* Developed symptoms of acute GE 72 hours after hospitalisation
* Stool sample should be positive for the presence of rotavirus, which will be detected either by Vikia test or by ELISA


* Family members including care-takers and sibling staying in the same house and who spend most of the nights (50%) with the sick child.
* Written permission from care-takers or siblings or their parents.

Exclusion Criteria

\- All children in the neonatal wards.
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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GSK Clinical Disclosure

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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Sweden

Other Identifiers

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109551

Identifier Type: -

Identifier Source: org_study_id