Acute upper respiratory tract infections (URTIs) in primary care Infections and Infestations
Conditions
Interventions
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 sa
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Previously participated in this study 2. Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactEmily;Andrew Brown;Turner
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Outcome results
None listed