Clinical trial NCT01563146: Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007
Official title: Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2006-2007
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Rotavirus
hospitals
Belgium
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.

Brief summary: This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.

Detailed description: This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. 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.

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.

Primary outcomes:
measure: Determination of the absolute number of rotavirus related hospitalisations in children up to five years old.
timeFrame: From June 1st 2006 up to 1 year
Secondary outcomes:
measure: Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status.
timeFrame: From June 1st 2006 up to 1 year
measure: Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort.
timeFrame: From June 1st 2006 up to 1 year
measure: Evaluation of the herd effect.
timeFrame: From June 1st 2006 up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Standaert B, Strens D, Pereira P, Benninghoff B, Raes M. Lessons Learned from Long-Term Assessment of Rotavirus Vaccination in a High-Income Country: The Case of the Rotavirus Vaccine Belgium Impact Study (RotaBIS). Infect Dis Ther. 2020 Dec;9(4):967-980. doi: 10.1007/s40121-020-00345-y. Epub 2020 Oct 6.
citation: Standaert B, Strens D, Li X, Schecroun N, Raes M. The Sustained Rotavirus Vaccination Impact on Nosocomial Infection, Duration of Hospital Stay, and Age: The RotaBIS Study (2005-2012). Infect Dis Ther. 2016 Dec;5(4):509-524. doi: 10.1007/s40121-016-0131-0. Epub 2016 Oct 6.
citation: Standaert B, Strens D, Alwan A, Raes M. Medium- to Long-Term Impact of Rotavirus Vaccination on Hospital Care in Belgium: A 7-Year Follow-Up of the Rotavirus Belgium Impact Study (RotaBIS). Infect Dis Ther. 2016 Mar;5(1):31-44. doi: 10.1007/s40121-015-0099-1. Epub 2015 Dec 31.