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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Belgium, hospitals, Rotavirus