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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563159
First received: March 1, 2012
Last updated: June 19, 2014
Last verified: June 2014
  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 Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2010-2011

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Classification of patients with rotavirus hospitalisation by age-group of 1-year, gender, time of the event, vaccine coverage status. [ Time Frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
Study Start Date: December 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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:

Not applicable.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563159

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563159     History of Changes
Other Study ID Numbers: 116312
Study First Received: March 1, 2012
Last Updated: June 19, 2014
Health Authority: Belgium: Ministry of Health

Keywords provided by GlaxoSmithKline:
Belgium
hospitals
Rotavirus

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

ClinicalTrials.gov processed this record on October 22, 2014