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

Infections, Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563159
• Other study ID #: 116312
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: March 13, 2018
• Start date: March 31, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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:

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)