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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202201
First Posted: September 15, 2010
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Nosocomial Rotavirus Gastroenteritis Rotavirus Gastroenteritis Other: Database analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis [ Time Frame: 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) ]
  • Seasonal distribution (monthly) of rotavirus gastroenteritis infection [ Time Frame: 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) ]
  • 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) ]

Enrollment: 13767
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202201


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01202201     History of Changes
Other Study ID Numbers: 114131
First Submitted: September 14, 2010
First Posted: September 15, 2010
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases