InfluenzaNCT01521416
Cost of Illness Associated With Influenza in the UK
An observational study of Influenza, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Data collection
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not Applicable
About this study
Official title: The Cost of Illness Associated With Influenza in the UK
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.
Read the detailed description
This is a retrospective, cross sectional, exploratory, observational study using database analysis and therefore there is no patient or user group involvement.
- Conditions
- Influenza
- Being tested
- Data collection
- Keywords
- Illness, Influenza, Cost, UK
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of influenza-related events
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Number of confirmed influenza infections
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Assessment of resource use
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Evaluation of patient outcomes, treatments and costs (type and duration)
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Cause of deaths
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Incidence of influenza-related events in High Risk groups
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Incidence of complications and exacerbations
Measured: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521416
- Sponsor's protocol ID
- 116313
- Status last verified
- Aug 2013
- First submitted
- 26 Jan 2012
- Last updated
- 2 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost of Illness Associated With Influenza in the UK
- ClinicalTrials.gov ID
- NCT01521416
- Acronym / sponsor ID
- 116313
- Conditions
- Influenza
- Keywords
- Illness, Influenza, Cost, UK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective, cross sectional, exploratory, observational study using database analysis and therefore there is no patient or user group involvement.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Group | – | Other: Data collection |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData 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. | Other | Cohort Group |
Primary outcome
Incidence of influenza-related events
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Number of confirmed influenza infections
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Assessment of resource use
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Evaluation of patient outcomes, treatments and costs (type and duration)
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Cause of deaths
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Incidence of influenza-related events in High Risk groups
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Incidence of complications and exacerbations
Time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of influenza-related events (time frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.