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

April 25, 2013 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From 1995 to 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From 1995 to 2009
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
From 1995 to 2009
Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.
Time Frame: From 1995 to 2009
From 1995 to 2009
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
From 1995 to 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Sage Analytica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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