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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706302
First Posted: October 15, 2012
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sage Analytica
Information provided by (Responsible Party):
GlaxoSmithKline
  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

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 ]

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 ]
  • 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 ]

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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706302


Sponsors and Collaborators
GlaxoSmithKline
Sage Analytica
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01706302     History of Changes
Other Study ID Numbers: 116357
First Submitted: October 11, 2012
First Posted: October 15, 2012
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by GlaxoSmithKline:
General Practice Research Database
Burden of Disease
Clinical Practice Research Datalink
Hospital Episode Statistics
Office of National Statistics
RSV