Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

March 13, 2018 updated by: GlaxoSmithKline

Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)

This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.

Description

Inclusion Criteria:

  • Child aged ≤5 years;
  • A stool sample has been provided for a rotavirus detection test during the study period;
  • Laboratory test result of rotavirus is available.

Exclusion Criteria:

Not applicable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
All children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2010 and May the 31st 2011.
Other: Data collection
Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute number of rotavirus related hospitalisations in children up to five years old.
Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of rotavirus positive tests on the total number of rota detection tests
Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Total number of rota detection tests and number of rotavirus positive tests of the study year will be determined by age-group of 1-year, gender, time of the event, vaccine coverage status.
During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
The duration of rota-related hospitalisation for community acquired and nosocomial infection.
Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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