NCT01521416

Brief Summary

The objective of this study is to describe the burden associated with influenza in the UK, from both primary and secondary care perspectives, and to stratify the burden by the annual degree of mismatch between predicted and actual virus strains.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

January 26, 2012

Last Update Submit

August 29, 2013

Conditions

Keywords

IllnessInfluenzaCostUK

Outcome Measures

Primary Outcomes (7)

  • Incidence of influenza-related events

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

  • Number of confirmed influenza infections

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

  • Assessment of resource use

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

  • Evaluation of patient outcomes, treatments and costs (type and duration)

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

  • Cause of deaths

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

  • Incidence of influenza-related events in High Risk groups

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

  • Incidence of complications and exacerbations

    Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Study Arms (1)

Cohort Group

Other: Data collection

Interventions

Data of patients diagnosed with acute respiratory illness is extracted from General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Health Protection Agency (HPA), Office of National Statistics (ONS), and National Health Service (NHS) Reference Costs, during the period January 21st 2001 and March 31st 2009 inclusive. All analyses of primary care data (GPRD) and separately for secondary care (HES) data will be repeated for all eligible patients, and the subset of patients with a linkage to additional data (HES, ONS). All analysis including secondary care data will be restricted to the subset of patients with linked HES data. Estimates of average burden per patient and total burden in the UK will be performed. Burden is defined as both resource use and cost. Annual incidence and burden will be calculated.

Cohort Group

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients coded within the relevant database (GPRD and HES) as having acute respiratory events that could be related to an infection between 2001 and 2009.

You may qualify if:

  • Male or female patients coded within the database as having acute respiratory events that could be related to an infection between 2001 and 2009.
  • Patients must have a minimum of 14 days observation before and after the index event to permit the capturing of complications attributable to influenza.

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 30, 2012

Study Start

June 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 2, 2013

Record last verified: 2013-08