Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009

This study has been completed.

Sponsor:

Collaborator:

Sage Analytica

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01706302

First received: October 11, 2012

Last updated: April 25, 2013

Last verified: April 2013

History of Changes

Purpose

The study will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.

Condition	Intervention
Respiratory Syncyctial Virus Vaccines	Other: Data collection

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom, 1995 to 2009

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes. [ Time Frame: From 1995 to 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes. [ Time Frame: From 1995 to 2009 ] [ Designated as safety issue: No ]
Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group. [ Time Frame: From 1995 to 2009 ] [ Designated as safety issue: No ]
Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations. [ Time Frame: From 1995 to 2009 ] [ Designated as safety issue: No ]
Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group. [ Time Frame: From 1995 to 2009 ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	October 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort Group Not Applicable	Other: Data collection The previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.

Groups/Cohorts

Assigned Interventions

Cohort Group

Not Applicable

Other: Data collection

The previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.

Detailed Description:

This epidemiological study is based on an already existing database of time series regression modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study, which estimated the burden of influenza in terms of General Practitioner (GP) consultations, hospitalizations, and deaths associated with various respiratory and non-respiratory outcomes.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects included in the 116273 study who were registered with an acceptable flag in the CPRD, or with a potentially RSV-related event in the HES database or the ONS mortality data.

Criteria

Inclusion Criteria:

• Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.

Exclusion Criteria:

• Not Applicable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706302

Sponsors and Collaborators

GlaxoSmithKline

Sage Analytica

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01706302 History of Changes
Other Study ID Numbers:	116357
Study First Received:	October 11, 2012
Last Updated:	April 25, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

General Practice Research Database
Burden of Disease
Clinical Practice Research Datalink

Hospital Episode Statistics
Office of National Statistics
RSV

Additional relevant MeSH terms:

Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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