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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563159
First Posted: March 26, 2012
Last Update Posted: September 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Infections, Rotavirus Other: Data collection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Absolute number of rotavirus related hospitalisations in children up to five years old. [ Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) ]

Secondary Outcome Measures:
  • Proportion of rotavirus positive tests on the total number of rota detection tests [ Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) ]
    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.

  • The duration of rota-related hospitalisation for community acquired and nosocomial infection. [ Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) ]

Estimated Enrollment: 1
Actual Study Start Date: March 31, 2015
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
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
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563159


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563159     History of Changes
Other Study ID Numbers: 116312
First Submitted: March 1, 2012
First Posted: March 26, 2012
Last Update Posted: September 5, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Belgium
hospitals
Rotavirus

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases