Point of care testing to inform care for chest infections in older adults in primary care: a randomised feasibility study
| ISRCTN | ISRCTN17439969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17439969 |
| Integrated Research Application System (IRAS) | 341760 |
| Protocol serial number | 93645.A2 |
| Sponsor | University of Southampton |
| Funder | National Institute for Health Research Southampton Biomedical Research Centre |
- Submission date
- 10/11/2025
- Registration date
- 05/01/2026
- Last edited
- 05/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Many people visit their GP with chest infections that feel like the flu. These infections are often caused by viruses, but antibiotics only work against bacteria. Despite this, antibiotics are still often prescribed, especially for older adults, because it can be hard to tell what kind of infection someone has. Taking antibiotics when they’re not needed can cause side effects and lead to antibiotic resistance, which makes it harder to treat infections in the future. This study is testing whether using quick tests, called point-of-care tests, during GP appointments can help doctors decide if antibiotics are really needed. The study is a small trial to see if a larger one would be possible in the future.
Who can participate?
You may be able to take part if you are aged 65 or over, have had symptoms of a chest infection (like a cough) for less than 7 days, and also have at least one of the following: shortness of breath, phlegm (sputum), or chest pain. You must also be able to give written consent to take part.
What does the study involve?
If you take part, you’ll be randomly placed into one of three groups. Each group will have a different type of quick test done during your GP appointment. One group will have a test for COVID-19 and flu. Another group will have the same test plus a test called FebriDx, which looks for signs of bacterial infection. The third group will have the COVID-19 and flu test plus a test for CRP, a marker of inflammation. Your GP will use the results to help decide whether antibiotics are needed. The study will also ask for your feedback and check how well the process works.
What are the possible benefits and risks of participating?
You may benefit by getting a more accurate diagnosis and avoiding unnecessary antibiotics. This could reduce side effects and help protect antibiotics for the future. There are very few risks, but as with any test, there’s a small chance of discomfort or a false result. You’ll be fully informed before you decide to take part.
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
February 2025 to April 2026
Who is funding the study?
National Institute for Health Research Southampton Biomedical Research Centre (UK)
Who is the main contact?
Jenna Garrod, jhg1u23@soton.ac.uk
Contact information
Principal investigator
Aldermoor Surgery, Off Aldermoor Cl, Coxford Rd
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0001-8309-568X |
|---|---|
| Phone | +44 23 8024 1000 |
| m.lown@soton.ac.uk |
Public, Scientific
Aldermoor Surgery, Off Aldermoor Cl, Coxford Rd
Southampton
SO16 5ST
United Kingdom
| Phone | +44 23 8024 1000 |
|---|---|
| jhg1u23@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled interventional feasibility trial with no blinding |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 48455 Participant Information Sheet V1.3 05Nov24.pdf |
| Scientific title | Point of care testing to reduce unnecessary antibiotic use for lower respiratory tract infections in older adults in primary care: a randomised feasibility trial |
| Study acronym | POCT65ABX |
| Study objectives | Aim: To explore the feasibility of a trial investigating using, and evaluating the use of, pathogen-detection point-of-care tests to help guide the management of LRTIs in older adults in a primary care setting. Objectives: 1. To assess the feasibility of conducting a trial investigating the use of lateral flow type point-of-care testing to improve the management of older adults with LRTIs in primary care, including recruitment, randomisation, and data collection. 2. To understand the acceptability of, and barriers and facilitators to using COVID-19 and Influenza A/B lateral flow type tests, with and without biomarker point-of-care tests, to help guide the management of lower respiratory tract infections (LRTI) in older adults in primary care. 3. To estimate the effects of using these tests on use of antimicrobials, in order to inform a future sample size calculation. 4. To understand the experiences of people with RTIs and primary care clinicians on point-of-care testing for respiratory viruses and biomarkers, and its effect on prescribing. |
| Ethics approval(s) |
Approved 26/11/2024, East of Scotland Ethic Committee (East of Scotland Research Ethics Service Tayside Academic Health Sciences Centre Residency Block Level 3 George Pirie Way Ninewells Hospital & Medical School, Dundee, DD1 9SY, United Kingdom; +44 1382 383839; TAY.eosres@nhs.scot), ref: 24/ES/0077 |
| Health condition(s) or problem(s) studied | Respiratory tract infections, antibiotic resistance |
| Intervention | Group 1 – A Covid/Flu lateral flow test will be performed using a nasal swab. This test takes around 10 mins to perform. Group 2A – A Covid/Flu lateral flow test will be performed using a nasal swab. As well as this, FebriDx will also be performed. This test shows if the participant has elevated levels of CRP (an inflammatory biomarker indicative of a bacterial infection) or MxA (A marker of the antiviral immune response indicative of a viral infection). Group 2B – A Covid/Flu lateral flow test will be performed using a nasal swab. As well as this, a SureScreen CRP test will be performed. This test shows if the participant has elevated levels of CRP (an inflammatory biomarker indicative of a bacterial infection) at three different levels – 10ug/l, 40ug/l, 80mg/l Group 3 – Usual Care All treatment is to be decided by the clinician and does not need to follow the advice of the tests. Both initial prescribing decision and final prescribing decision after the tests have been complete will be logged. Randomisation is done using a program called sealed envelope. This is set up to stratify randomisation by the initial prescribing decision. The clinician simply needs to input patient ID, initial prescribing decision and if they are eligible for the study and they will be randomised. The participant will need to complete a 28 day follow up diary. Everyday they will rank their symptoms from a list from a scale of 0-6 with 0 being not at all and 6 being very severe. Once a week, patients will note down if they have received any antibiotics or antivirals for their consulting chest infection, if they’ve seen a GO again, if they’ve been hospitalised, been to A&E or an out of hours centre. After 14 days, the first half of the diary will be returned by freepost envelope and the same again after 28 days with the latter half. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FebriDx, SureScreen Covid-19/Influenza A/B lateral flow dual cassette, SureScreen CRP Test |
| Primary outcome measure(s) |
Feasibility outcome measures: |
| Key secondary outcome measure(s) |
Exploratory outcome measures: |
| Completion date | 28/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 180 |
| Key inclusion criteria | 1. Age 65 years or over 2. Presenting to primary care with symptoms of a lower respiratory tract infection beginning less than seven days prior to appointment. Symptoms must include an acute cough and one other symptom: 2.1. Shortness of breath 2.2. Sputum 2.3. Chest pain 3. The ability to provide written informed consent |
| Key exclusion criteria | 1. Clinical diagnosis of pneumonia 2. Patient is already receiving antibiotics and/or antivirals or has used antibiotics/antivirals in the past 30 days. 3. Patient declines URT swabbing or finger prick blood testing. 4. Patient has cystic fibrosis 5. Patient has bronchiectasis 6. Patient is terminally ill 7. Patient is unable to comply with trial procedures 8. Patient has dementia, and/or is not able to consent themselves to trial procedures |
| Date of first enrolment | 04/03/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Hayling Island
PO11 9AP
England
26 High Street
Buckingham
MK18 1NU
England
Oxford
OX4 1XB
England
Waterlooville
PO8 8DL
England
Didcot
OX11 7JH
England
Headington
Oxford
OX3 9JA
England
Alton
GU34 1RJ
England
Didcot
OX11 0BB
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | As is standard, an “open as possible, closed as necessary” stance will be taken when it comes to data sharing. Underlying data for the final thesis will be deposited in the institutional research repository via PURE. A DOI will be requested, and access will be agreed with the supervisory team. Data will be licensed for reuse using a Creative Commons licence. The data used will be cited in the final thesis under accompanying materials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 05/11/2024 | 26/11/2025 | No | Yes |
| Protocol file | version 1.3 | 28/10/2024 | 26/11/2025 | No | No |
Additional files
- 48455 Participant Information Sheet V1.3 05Nov24.pdf
- Participant information sheet
- 48455 Feasibility Study Protocol V1.3 28Oct24.pdf
- Protocol file
Editorial Notes
11/11/2025: Trial's existence confirmed by NHS HRA.
