Influenza, HumanNCT02984280
Specific Respiratory Infections as Triggers of Acute Medical Events
An observational study of Influenza, Human and Respiratory Syncytial Virus Infections, run by University College, London at 1 site in United Kingdom.
Trial summary
This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Influenza, Human, Respiratory Syncytial Virus Infections, Parainfluenza
- How many people
- 787,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Mar 2017
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population of England who have received NHS care during the study period.
Who may be able to join
- Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for myocardial infarction or stroke) within the study period aged 45+ years
- Any individual with a record of an eligible exposure (laboratory-confirmed respiratory virus) within the study period at any age
Who cannot join
- Outcome events occurring in people aged <45 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Respiratory Infections as Triggers of Acute Medical Events: Time Series Analysis Using LabBase and Hospital Episode Statistics
This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.
Read the detailed description
We will conduct a time series study correlating anonymised population level data on all samples from NHS laboratories testing positive for six common respiratory viruses with admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models controlling for factors such as seasonal and long-term trends, environmental temperature and humidity.
This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.
- Conditions
- Influenza, Human, Respiratory Syncytial Virus Infections, Parainfluenza, Rhinovirus, Adenovirus, Human Metapneumovirus Pneumonia
- Medical subject headings
- Influenza, Human, Respiratory Syncytial Virus Infections, Paramyxoviridae Infections, Adenoviridae Infections, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute myocardial infarction
ICD-10 coded
Measured: 01/01/2004 to 31/12/2014
Stroke
ICD-10 coded
Measured: 01/01/2004 to 31/12/2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 787,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
- Investigators
- Charlotte MJ Warren-Gash, MRCP PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984280
- Sponsor's protocol ID
- 15/0440
- Status last verified
- Nov 2016
- First submitted
- 2 Dec 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Blackburn R, Zhao H, Pebody R, Hayward A, Warren-Gash C. Laboratory-Confirmed Respiratory Infections as Predictors of Hospital Admission for Myocardial Infarction and Stroke: Time-Series Analysis of English Data for 2004-2015. Clin Infect Dis. 2018 Jun 18;67(1):8-17. doi: 10.1093/cid/cix1144.
PubMed 29324996
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Respiratory Infections as Triggers of Acute Medical Events: Time Series Analysis Using LabBase and Hospital Episode Statistics
- ClinicalTrials.gov ID
- NCT02984280
- Acronym / sponsor ID
- 15/0440
- Conditions
- Influenza, Human, Respiratory Syncytial Virus Infections, Parainfluenza, Rhinovirus, Adenovirus, Human Metapneumovirus Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 787,000 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Dec 2016 (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.
This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.
Detailed description
We will conduct a time series study correlating anonymised population level data on all samples from NHS laboratories testing positive for six common respiratory viruses with admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models controlling for factors such as seasonal and long-term trends, environmental temperature and humidity.
This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population of England who have received NHS care during the study period.
Key inclusion criteria (2 listed)
- Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for myocardial infarction or stroke) within the study period aged 45+ years
- Any individual with a record of an eligible exposure (laboratory-confirmed respiratory virus) within the study period at any age
Key exclusion criteria (1 listed)
- Outcome events occurring in people aged <45 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute myocardial infarction
Time frame: 01/01/2004 to 31/12/2014
ICD-10 coded
Stroke
Time frame: 01/01/2004 to 31/12/2014
ICD-10 coded
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 4 May 2017.
- Derived from this study: PubMed 29324996Blackburn R, Zhao H, Pebody R, Hayward A, Warren-Gash C. Laboratory-Confirmed Respiratory Infections as Predictors of Hospital Admission for Myocardial Infarction and Stroke: Time-Series Analysis of English Data for 2004-2015. Clin Infect Dis. 2018 Jun 18;67(1):8-17. doi: 10.1093/cid/cix1144.
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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.
Charlotte MJ Warren-Gash, MRCP PhD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human and Respiratory Syncytial Virus Infections, run by University College, London at 1 site in United Kingdom.
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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Acute myocardial infarction (time frame: 01/01/2004 to 31/12/2014). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984280, which also lists 1 linked publication.
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 4 May 2017.