Improving antibiotic use for upper respiratory infections in GP practices
| ISRCTN | ISRCTN10224525 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10224525 |
| IRAS number | 332965 |
| Secondary identifying numbers | CPMS 63637 |
- Submission date
- 29/11/2024
- Registration date
- 10/12/2024
- Last edited
- 20/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Antibiotics only work for infections caused by bacteria. They do not work if the infection is caused by a virus. If antibiotics are given too often, they can stop working. When antibiotics stop working this is called antimicrobial resistance (AMR). This means infections caused by bacteria are difficult to treat and people might die. By 2050, AMR could cause more deaths than cancer.
Using fewer antibiotics means less AMR. Most antibiotics are given in GP practices. The reason too many antibiotics are given is because it is often hard to tell if an infection is caused by bacteria or by a virus. Antibiotics are often given for infections caused by viruses, like sore throats and sinus infections. Infections in the ear, throat, nose or sinuses, but not the lungs, are known as upper respiratory infections. The UK government wants tests that can show if an infection is bacterial or viral. Quick tests, used close to where patients are seen, like GP practices, are called point-of-care tests (POCTs).
A new, quick POCT, called FebriDx®, uses a tiny ‘finger-prick’ blood sample to measure how a patient’s immune system is reacting to the infection. The result can help healthcare staff know if the infection is viral or bacterial. This POCT has been used in hospitals, but not in GP practices. This study aims to find out if FebriDx® will work in GP practices.
Who can participate?
Patients aged 1 year and over with symptoms of upper respiratory infections
What does the study involve?
The researchers will invite GP practices to test adults and children with upper respiratory infections using FebriDx®. They want to know:
1. How often healthcare staff use the test and who they test
2. If the test changes what healthcare staff think caused the infection and whether antibiotics are needed
3. How good the test is at telling the difference between viral and bacterial infections
The researchers will interview patients, GPs, nurses and other staff to find out how they got on with the test.
What are the possible benefits and risks of participating?
If the test is practical, acceptable to patients, and may reduce antibiotic use, the researchers plan to do a larger study to find out if this test can be used in all GP practices to help reduce antibiotic use and the amount of AMR.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
September 2024 to August 2025
Who is funding the study?
NIHR School for Primary Care Research (UK)
Who is the main contact?
1. Dr Emily Brown, emily.brown@bristol.ac.uk
2. Dr Andrew Turner, andrew.turner@bristol.ac.uk
Contact information
Public, Scientific, Principal Investigator
Centre of Academic Primary Care
Population Health Sciences
Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-8232-1769 |
|---|---|
| Phone | +44 (0)117 928 7279 |
| emily.brown@bristol.ac.uk |
Public
Centre of Academic Primary Care
Population Health Sciences
Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| ORCID ID |
0000-0002-7121-3121 |
|---|---|
| Phone | +44 (0)117 455 9657 |
| andrew.turner@bristol.ac.uk |
Study information
| Study design | Prospective feasibility cohort study with qualitative evaluation and exploration of diagnostic accuracy |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Host immune response point-of-care testing for children and adults presenting to primary care with acute upper respiratory tract infection: a mixed-methods feasibility study |
| Study acronym | RAPID IMMUNE TEST |
| Study objectives | To investigate the feasibility and value of FebriDx® use for children and adults with acute URTIs in primary care, and inform the design of a future randomised-controlled trial (RCT). |
| Ethics approval(s) | Approved 16/10/2024, West of Scotland REC 4 (Research Ethics, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 24/WS/0109 |
| Health condition(s) or problem(s) studied | Acute upper respiratory tract infections (URTIs) in primary care |
| Intervention | The Host Response Point-Of-Care Test (POCT HR) device that we will use in this study is FebriDx® (Lumos Diagnostics), a novel combination POCT HR. FebriDx® has advantages for primary care use; it is dual-marker, hand-held, rapid turnaround (10 minutes) and does not require an additional desktop analyser. It is the only combination POCT HR using a ‘finger-prick’ (rather than venous) blood sample. It has indicators of both viral (myxovirus resistance protein A, MxA) and bacterial (CRP) host immune response. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | FebriDx Point-of-Care Test Device |
| Primary outcome measure | Clinician pre- and post-test diagnostic confidence measured using a clinician survey on case report forms completed before and after the FebriDx test is performed |
| Secondary outcome measures | 1. Percentage of eligible patients in whom FebriDx® is used, measured using a patient identification form when potentially eligible patients present at their general practice 2. Clinical and demographic characteristics of patients in whom FebriDx® is used, measured using the pre-test case report form at the start of their consultation 3. Job type and number of staff using FebriDx® measured using the pre-test case report form at the start of each consultation 4. Distribution of FebriDx® results (viral/bacterial/negative/invalid) measured using a post-test case report form at the end of the consultation 5. Clinician pre- and post-test belief that antibiotic treatment is necessary, measured using a clinician survey on case report forms completed before and after the FebriDx test is performed 6. The proportion of patients prescribed antibiotics after FebriDx® measured using a post-test case report form at at the end of the consultation 7. Sensitivity and specificity for acute bacterial URTI (TaqMan array analysis of nasal/throat swabs will enable assessment of microbial prevalence, burden and viral/bacterial diversity in the URT) at the end of the study 8. Re-consultation and antibiotic prescribing events within 30 days following study recruitment measured using a notes review case report form 9. Hospitalisations and death within 30 days following study recruitment measured using a notes review case report form |
| Overall study start date | 01/09/2024 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 1 Year |
| Sex | Both |
| Target number of participants | Planned Sample Size: 231; UK Sample Size: 231 |
| Total final enrolment | 249 |
| Key inclusion criteria | 1. Age ≥12 months being assessed (face-to-face or remote, but willing to attend in person for study tests) for symptoms of acute (≤21 days) URTI as identified by the recruiting clinician, including sore throat/pharyngitis/laryngitis, acute middle ear infections (acute otitis media), sinusitis or cough but without symptoms or signs localising to the lower respiratory tract (shortness of breath, wheeze, sputum, chest pain) 2. The clinician has decided that they are likely to prescribe antibiotics in the absence of further diagnostic testing (to prevent over-medicalisation of URTIs) 3. Clinician and patient willing to wait for POCT result before finalising treatment plan |
| Key exclusion criteria | 1. Previously participated in this study 2. Age <12 months 3. Symptoms or signs of lower respiratory tract involvement, such as new shortness of breath, wheeze, sputum, chest pain 4. Present with symptoms >21 days 5. Patient unable to receive study tests from the GP practice before a prescribing decision is made 6. Current use of antibiotic or antiviral medication 7. Patients who are immunosuppressed 8. Live viral immunisation within the last 30 days 9. Adults lacking capacity to consent for themselves 10. Prisoners or young offenders in the custody of HM Prison Service or who are offenders supervised by the probation service 11. Study samples cannot be transported to laboratory to be received within 48 hours of being taken |
| Date of first enrolment | 25/11/2024 |
| Date of final enrolment | 16/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
Research Governance Team
Research & Enterprise Division
Augustine's Courtyard
Orchard Lane
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 (0)1173940177 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Private sector organisation / Universities (academic only)
- Alternative name(s)
- School for Primary Care Research, NIHR SPCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Patients and members of the public helped design this study, agreed it is worth doing and that the ‘finger-prick’ test was the right test to use. The researchers will work with this group to review study documents and decide how the study should progress and what the results mean. The researchers will share their results with: 1. The public, using their website, social media and local events 2. The research community in scientific publications and at conferences 3. The NHS and policymakers All results in journals and presentations will be anonymous. A summary of findings will be provided to participants, and study progress and results will be made available via appropriate websites and social media feeds. Further avenues for output may also be explored after consultation with PPI members. |
| IPD sharing plan | The datasets generated during the study will be stored in a publicly available repository, through controlled access: https://data.bris.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 0.5 | 09/07/2024 | 03/12/2024 | No | No |
Additional files
Editorial Notes
20/05/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 19/05/2025 to 16/05/2025.
2. The total final enrolment was added.
18/03/2025: The recruitment end date was changed from 31/03/2025 to 19/05/2025.
29/11/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
