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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01521416
Other study ID # 116313
Secondary ID
Status Completed
Phase N/A
First received January 26, 2012
Last updated August 29, 2013
Start date June 2011
Est. completion date April 2013

Study information

Verified date August 2013
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial 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.


Description:

This is a retrospective, cross sectional, exploratory, observational study using database analysis and therefore there is no patient or user group involvement.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Data collection
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of influenza-related events Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
Primary Number of confirmed influenza infections Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
Primary Assessment of resource use Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
Primary Evaluation of patient outcomes, treatments and costs (type and duration) Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
Primary Cause of deaths Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
Primary Incidence of influenza-related events in High Risk groups Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
Primary Incidence of complications and exacerbations Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) No
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