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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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