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

Rotavirus Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202201
• Other study ID #: 114131
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: June 6, 2017
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13767
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteritis
• Nosocomial Rotavirus Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Other:
• Database analysis
Review and collect data from database (electronic admission database or any other applicable database of the hospital)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of acute gastroenteritis among all hospitalized children aged <6 years		At least 24 months (from 01 January 2008 to 31 December 2009)
Primary	Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years		At least 24 months (from 01 January 2008 to 31 December 2009)
Primary	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)
Secondary	Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years		At least 24 months (from 01 January 2008 to 31 December 2009)
Secondary	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)
Secondary	Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis		At least 24 months (from 01 January 2008 to 31 December 2009)
Secondary	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)
Secondary	Seasonal distribution (monthly) of rotavirus gastroenteritis infection		At least 24 months (from 01 January 2008 to 31 December 2009)
Secondary	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)
Secondary	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)