Clinical trial NCT01202201: A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Rotavirus Gastroenteritis
Rotavirus Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 13767
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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.

Primary outcomes:
measure: Occurrence of acute gastroenteritis among all hospitalized children aged <6 years
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
Secondary outcomes:
measure: Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Occurrence of nosocomial rotavirus gastroenteritis among all hospitalizations with rotavirus gastroenteritis in children aged <6 years
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Occurrence of rotavirus gastroenteritis hospitalization and nosocomial rotavirus gastroenteritis hospitalization among children <6 years of age, stratified by age
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Seasonal distribution (monthly) of rotavirus gastroenteritis infection
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Age (monthly) specific data of all the outcome measures, for children <12 months of age
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
measure: Number of hospitalizations with rotavirus gastroenteritis and other vaccine-preventable infectious diseases such as influenza, mumps and varicella among children <6 years of age
timeFrame: At least 24 months (from 01 January 2008 to 31 December 2009)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Tajiri H, Takeuchi Y, Takano T, Ohura T, Inui A, Yamamoto K, Higashidate Y, Kawashima H, Toyoda S, Ushijima K, Ramakrishnan G, Rosenlund M, Holl K. The burden of rotavirus gastroenteritis and hospital-acquired rotavirus gastroenteritis among children aged less than 6 years in Japan: a retrospective, multicenter epidemiological survey. BMC Pediatr. 2013 May 22;13:83. doi: 10.1186/1471-2431-13-83.