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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01202201
Enrollment
13767
Registered
2010-09-15
Start date
2010-09-30
Completion date
2011-02-28
Last updated
2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nosocomial Rotavirus Gastroenteritis, Rotavirus Gastroenteritis

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.

Interventions

Review and collect data from database (electronic admission database or any other applicable database of the hospital)

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Occurrence of acute gastroenteritis among all hospitalized children aged <6 yearsAt least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 yearsAt least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 yearsAt least 24 months (from 01 January 2008 to 31 December 2009)

Secondary

MeasureTime frame
Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 yearsAt 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 yearsAt least 24 months (from 01 January 2008 to 31 December 2009)
Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritisAt 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 ageAt least 24 months (from 01 January 2008 to 31 December 2009)
Seasonal distribution (monthly) of rotavirus gastroenteritis infectionAt 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 ageAt 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 ageAt least 24 months (from 01 January 2008 to 31 December 2009)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026