Completed

NCT Number: NCT01706302

Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncyctial Virus Vaccines

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

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

Secondary outcomes

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
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
Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.

Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

Sage Analytica

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Oct 15, 2012
Registry last updated: Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.