Last updated: 01/05/2021 09:40:05
Number of rotavirus (RV) related hospitalizations in Belgium – season 2010-2011
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Assessing the rotavirus positive test results in 11 hospitals in Belgium from 2005 to 2013: the RotaBIS study (Rotavirus Belgian Impact Study)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Absolute number of rotavirus related hospitalisations in children up to five years old.
Timeframe: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Secondary outcomes:
Proportion of rotavirus positive tests on the total number of rota detection tests
Timeframe: 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.
Timeframe: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Interventions:
Other: Data collection
Enrollment:
1
Observational study model:
Ecologic or Community
Primary completion date:
2017-31-12
Time perspective:
Retrospective
Clinical publications:
Standaert B et al. (2016) The sustained rotavirus vaccination impact on nosocomial infection, duration of hospital stay, and age: the RotaBIS study (2005-2012). Infect Dis Ther. 5(4):509-524.
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.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
March 2015 to December 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 5 years
Accepts healthy volunteers
No
- Child aged ≤5 years;
- A stool sample has been provided for a rotavirus detection test during the study period;
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- A stool sample has been provided for a rotavirus detection test during the study period;
- Laboratory test result of rotavirus is available.
Child aged ≤5 years;
Exclusion criteria:
- Not applicable.
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2017-31-12
Actual study completion date
2017-31-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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