Nosocomial Rotavirus GastroenteritisNCT01202201
A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan
An observational study of Nosocomial Rotavirus Gastroenteritis and Rotavirus Gastroenteritis, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Nosocomial Rotavirus Gastroenteritis, Rotavirus Gastroenteritis
- What is being tested?
- Database analysis
- How many people
- 13,767 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children <6 years of age hospitalized with acute gastroenteritis or rotavirus gastroenteritis in any of the participating hospitals
Who may be able to join
- 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.
Who cannot join
- Participants of any kind of rotavirus vaccine clinical trial.
About this study
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
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.
Read the 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.
- Being tested
- Database analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Database analysisOther
Review and collect data from database (electronic admission database or any other applicable database of the hospital)
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis Receives: Other: Database analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of acute gastroenteritis among all hospitalized children aged <6 years
Measured: At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years
Measured: 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
Measured: At least 24 months (from 01 January 2008 to 31 December 2009)
Secondary outcomes (7)
Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years
Measured: 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
Measured: At least 24 months (from 01 January 2008 to 31 December 2009)
Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis
Measured: 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
Measured: At least 24 months (from 01 January 2008 to 31 December 2009)
Seasonal distribution (monthly) of rotavirus gastroenteritis infection
Measured: 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
Measured: 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
Measured: At least 24 months (from 01 January 2008 to 31 December 2009)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nosocomial Rotavirus GastroenteritisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202201
- Sponsor's protocol ID
- 114131
- Status last verified
- Jun 2017
- First submitted
- 14 Sep 2010
- Last updated
- 7 Jun 2017
- Results posted
- No
Publications
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.
PubMed 23697664
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01202201
- Acronym / sponsor ID
- 114131
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,767 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Database analysisSubjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children <6 years of age hospitalized with acute gastroenteritis or rotavirus gastroenteritis in any of the participating hospitals
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants of any kind of rotavirus vaccine clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Database analysisReview and collect data from database (electronic admission database or any other applicable database of the hospital) | Other | Study Cohort |
Primary outcome
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)
7 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Derived from this study: PubMed 23697664Tajiri 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Rotavirus Gastroenteritis and Rotavirus Gastroenteritis, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01202201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.