Molecular point-of-care 'test and treat' for influenza (FluPOC)
| ISRCTN | ISRCTN17197293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17197293 |
| EudraCT/CTIS number | N/A |
| Secondary identifying numbers | 35478 |
- Submission date
- 06/11/2017
- Registration date
- 13/11/2017
- Last edited
- 18/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Influenza causes thousands of people to become unwell and be admitted to hospital every year. There is a vaccine available to prevent influenza but not everybody receives it and some of those who do still catch influenza and become unwell. There are antiviral drugs available to treat influenza but they are not used as often as they should be. This is because patients admitted to hospital with influenza are not always tested for it and when they are, the standard test takes 24-48 hours to give a result. Recent studies have shown that antiviral drugs are very helpful in unwell patients admitted to hospital with influenza and so we must find a way to improve the numbers of patients who are diagnosed with influenza and treated with antivirals. There is a new test which is very accurate, gives results within one hour and can be used at the bedside as soon as patients come into hospital. By using this test in patients admitted to hospital it may improve the number of cases of influenza diagnosed and increases the number given antivirals. This study will evaluate the impact of a routine molecular point-of-care ‘test and treat’ strategy for influenza in adults hospitalised with acute respiratory illness.
Who can participate?
Patients aged 18 and older who have come in the emergency department for respiratory illness.
What does the study involve?
Participants are randomly allocated to one of two groups. One group has a nose and throat swab taken and the new test performed as soon as they come into hospital and the results given to the doctors and the patient. Patients with a positive test for influenza are offered antiviral medicines in accordance with UK guidelines. Those in the second group are managed in the standard way where doctors decide whether or not to send a test to the laboratory and then whether to offer antiviral medicines. The two groups are compared to see if having the new rapid test made any difference to their care or outcome.
What are the possible benefits and risks of participating?
Patients in the group with the new test may benefit from having their results much sooner than normal. Patents in the control group are not expected to benefit directly from being in the study. The risks of respiratory tract sampling and additional blood tests being taken are minimal and where occurring are likely to be mild. No additional adverse events related to POCT for respiratory viruses are anticipated.
Where is the study run from?
1. Southampton General Hospital (UK)
2. Royal Hampshire County Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2015 to May 2026
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Tristan Clark (Scientific)
t.w.clark@soton.ac.uk
Contact information
Scientific
University of Southampton and University Hospital Southampton NHS Foundation Trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2381208410 |
|---|---|
| t.w.clark@soton.ac.uk |
Study information
| Study design | Multicentre; Randomised; Interventional; Design type: Diagnosis, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pragmatic, multicentre, randomised controlled trial evaluating a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness: FluPOC |
| Study acronym | FluPOC |
| Study objectives | A routine molecular Point-of-Care 'test and treat' strategy for influenza improves the care of adults hospitalised with acute respiratory illness. |
| Ethics approval(s) | Regional Ethics Committee (REC): South Central - Hampshire A Research Ethics Committee, 07/09/2017, ref: 17/SC/0368 |
| Health condition(s) or problem(s) studied | Infection |
| Intervention | Current: This study is a pragmatic, multi-centre, randomised controlled trial in adults with ARI admitted to University Hospital Southampton NHS Foundation Trust or Hampshire Hospitals Foundation NHS Trust, during influenza season. Previous: This study is a pragmatic, single-centre, randomised controlled trial in adults with ARI admitted to University Hospital Southampton NHS Foundation Trust, during influenza season. 840 patients are recruited over three influenza seasons and randomised (1:1) to receive either POCT using the FilmArray Respiratory Panel, or routine clinical care. Clinical and infection control teams are informed of the results in real time and where influenza is detected patients are offered NAI treatment immediately, in accordance with national guidelines. Those allocated to standard clinical care have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment is done by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality. |
| Intervention type | Other |
| Primary outcome measure | Difference in the proportion of influenza positive patients treated appropriately with neuraminidase inhibitors (NAI) within 5 days of admission. |
| Secondary outcome measures | 1. Proportion of cases of influenza identified 2. Proportion of cases of all respiratory viruses detected 3. Proportion of all NAI use occurring in influenza positive patients 4. Proportion of all NAI use occurring in influenza negative patients 5. Time from admission to NAI commencement in hours 6. Duration of NAI use in influenza positive patients, days and doses 7. Duration of NAI use in influenza negative patients, days and doses 8. Proportion of patients treated with antibiotics 9. Proportion of patients treated with single doses or brief courses (<48 hours) of antibiotics 10. Duration of antibiotic use in days 11. Proportion of patients isolated in a side room 12. Duration of isolation facility use 13. Proportion of influenza cases correctly isolated 14. Time from admission to isolation of influenza positive cases 15. Time from admission to de-isolation of influenza negative cases 16. Duration of hospitalisation in days 17. Time to clinical stability* in days 18. Time on supplementary oxygen in days 19. Proportion of patients with ICU or HDU admission 20. Duration of ICU or HDU stay in days 21. Proportion re-presenting to hospital within 30 days 22. Proportion readmitted to hospital within 30 days 23. In hospital, 30 and 60 day mortality 24. Turn-around time for viral testing All outcomes are measured for the duration of hospitalisation or up to 30 days (whichever is shortest) unless specified otherwise and include medication (antibiotics and NAIs) that patients are discharged home with. *Defined as: temperature ≤37.8C, respiratory rate ≤24 breaths per minute, heart rate ≤100 beats per minute, oxygen saturation ≥90% without the use of supplementary oxygen, systolic blood pressure ≥90 and normal mental status mmHg for at least 24 hours. |
| Overall study start date | 01/10/2015 |
| Completion date | 01/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 840; UK Sample Size: 840 |
| Total final enrolment | 613 |
| Key inclusion criteria | 1. Is a patient in the ED* or AMU at University Hospital Southampton NHS Foundation Trust (UHS) or [added 01/05/2019]: Hampshire Hospitals Foundation NHS Trust 2. Aged ≥18 years old 3. Has acute respiratory illness** 4. Duration of respiratory illness less than 10 days prior to hospitalisation 5. Can be recruited to the study within 16 hours of presentation *For patients in ED a decision will have already been made that the patient will be admitted. **An episode of acute respiratory illness is defined as an acute pulmonary illness (including pneumonia, bronchitis and influenza-like illness) or an acute exacerbation of a chronic respiratory illness (including exacerbation of COPD, asthma or bronchiectasis). For the study, acute respiratory illness as a provisional, working, differential or confirmed diagnosis must be made by a treating clinician. |
| Key exclusion criteria | 1. Not fulfilling all the inclusion criteria 2. A purely palliative approach being taken by the treating clinicians 3. Previously included in this study and re-presenting within the last 30 days after hospital discharge 4. Declines nasal / pharyngeal swabbing 5. Consent declined or consultee consent declined 6. Concurrent, prior or subsequent enrolment in an observational study is not necessarily an exclusion criterion; this is at the discretion of the chief investigator and will be assessed on a case-by-case basis. |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 17/05/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Tremona Road
Southampton
SO16 6YD
United Kingdom
Romsey Road
Winchester
S022 5DG
United Kingdom
Sponsor information
Hospital/treatment centre
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. Plans to publish protocol. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/12/2019 | 20/12/2019 | Yes | No |
| Results article | 01/04/2021 | 18/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
27/01/2020: The recruitment end date was changed from 01/05/2020 to 17/05/2019.
20/12/2019: Publication reference added.
01/05/2019: The following changes were made to the trial record:
1. The scientific title was changed from 'Pragmatic randomised controlled trial evaluating a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness: FluPOC' to 'Pragmatic, multicentre, randomised controlled trial evaluating a routine molecular Point-of-Care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness: FluPOC'.
2. The study design was changed from 'Randomised; Interventional; Design type: Diagnosis, Management of Care' to 'Multicentre; Randomised; Interventional; Design type: Diagnosis, Management of Care'.
3. The interventions and inclusion criteria were updated.
4. Royal Hampshire County Hospital was added as a trial participating centre.
29/03/2019: The condition has been changed from "Specialty: Infectious diseases and microbiology, Primary sub-specialty: Other; UKCRC code/ Disease: Infection/ Other infectious diseases" to "Infection" following a request from the NIHR.
