Clinical trial NCT01706302: Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009
Official title: Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom, 1995 to 2009
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncyctial Virus Vaccines
Keywords: General Practice Research Database
Burden of Disease
Clinical Practice Research Datalink
Hospital Episode Statistics
Office of National Statistics
RSV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Sage Analytica
First posted: 2012-10-15
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.
timeFrame: From 1995 to 2009
Secondary outcomes:
measure: 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.
timeFrame: From 1995 to 2009
measure: 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.
timeFrame: From 1995 to 2009
measure: Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.
timeFrame: From 1995 to 2009
measure: Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.
timeFrame: From 1995 to 2009
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Taylor S, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Fleming DM. Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open. 2016 Jun 2;6(6):e009337. doi: 10.1136/bmjopen-2015-009337.
citation: Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z.