A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan

Completed

• Conditions: Rotavirus Gastroenteritis; Nosocomial Rotavirus Gastroenteritis
• Interventions: Other: Database analysis

• Registration Number: NCT01202201
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children \< 6 years of age, in Japan.

Detailed Description

This is a retrospective database study wherein data on children who have been diagnosed with acute gastroenteritis or rotavirus gastroenteritis will be collected from the electronic admission database or any other applicable database of the participating hospitals.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13767

Inclusion Criteria

• A male or female child aged <6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday.
• A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period.

Exclusion Criteria

• Participants of any kind of rotavirus vaccine clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Cohort	Database analysis	Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis

Primary Outcome Measures

Name	Time	Method
Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years	At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of acute gastroenteritis among all hospitalized children aged <6 years	At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years	At least 24 months (from 01 January 2008 to 31 December 2009)

Secondary Outcome Measures

Name	Time	Method
Age (monthly) specific data of all the outcome measures, for children <12 months of age	At least 24 months (from 01 January 2008 to 31 December 2009)
Number of hospitalizations with rotavirus gastroenteritis and other vaccine-preventable infectious diseases such as influenza, mumps and varicella among children <6 years of age	At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years	At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of nosocomial rotavirus gastroenteritis among all hospitalizations with rotavirus gastroenteritis in children aged <6 years	At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of rotavirus gastroenteritis hospitalization and nosocomial rotavirus gastroenteritis hospitalization among children <6 years of age, stratified by age	At least 24 months (from 01 January 2008 to 31 December 2009)
Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis	At least 24 months (from 01 January 2008 to 31 December 2009)
Seasonal distribution (monthly) of rotavirus gastroenteritis infection	At least 24 months (from 01 January 2008 to 31 December 2009)