Last updated: 01/05/2021 09:40:05

Number of rotavirus (RV) related hospitalizations in Belgium – season 2010-2011

GSK study ID
116312
See study documents
Clinicaltrials.gov ID
NCT01563159
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2017-31-12
    Observational study model:
    Ecologic or Community
    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:

      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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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