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

June 6, 2017 updated by: GlaxoSmithKline

A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Children <6 Years of Age in Japan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

13767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children <6 years of age hospitalized with acute gastroenteritis or rotavirus gastroenteritis in any of the participating hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Cohort
Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis
Other: Database analysis
Review and collect data from database (electronic admission database or any other applicable database of the hospital)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
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
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
At least 24 months (from 01 January 2008 to 31 December 2009)
Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
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
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
At least 24 months (from 01 January 2008 to 31 December 2009)
Seasonal distribution (monthly) of rotavirus gastroenteritis infection
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
At least 24 months (from 01 January 2008 to 31 December 2009)
Age (monthly) specific data of all the outcome measures, for children <12 months of age
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
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
Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009)
At least 24 months (from 01 January 2008 to 31 December 2009)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 15, 2010

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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