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

NCT01563159 | Completed

• 1 other identifier: 116312
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infections, Rotavirus

Keywords

Belgium; hospitals; Rotavirus

Outcome Measures

Primary Outcomes (1)

• Absolute number of rotavirus related hospitalisations in children up to five years old.

  During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Secondary Outcomes (2)

• Proportion of rotavirus positive tests on the total number of rota detection tests

  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.

  During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)

Study Arms (1)

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

Interventions

Data collection OTHER

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.

Group A

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.

You may qualify if:

• 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.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 33025558 DERIVED

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 26, 2012
• Study Start: March 31, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03