Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

NCT01563146 | Completed

• 1 other identifier: 116311
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.

Conditions

Infections, Rotavirus

Keywords

Rotavirus; hospitals; Belgium

Outcome Measures

Primary Outcomes (1)

• Determination of the absolute number of rotavirus related hospitalisations in children up to five years old.

  From June 1st 2006 up to 1 year

Secondary Outcomes (3)

• Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status.

  From June 1st 2006 up to 1 year

• Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort.

  From June 1st 2006 up to 1 year

• Evaluation of the herd effect.

  From June 1st 2006 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 2006 and May the 31st 2007.

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 2006- May 31st 2007) 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 (3)

• 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

• Standaert B, Strens D, Li X, Schecroun N, Raes M. The Sustained Rotavirus Vaccination Impact on Nosocomial Infection, Duration of Hospital Stay, and Age: The RotaBIS Study (2005-2012). Infect Dis Ther. 2016 Dec;5(4):509-524. doi: 10.1007/s40121-016-0131-0. Epub 2016 Oct 6.

  PMID: 27714677 DERIVED

• 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. Epub 2015 Dec 31.

  PMID: 26721823 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: February 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03