Community-acquired acute respiratory tract infection Respiratory
Conditions
Interventions
This will be a multi-country, prospective, individually randomised, platform clinical trial in community care with a nested process evaluation. The trial will be a diagnostic strategy intervention stu
OR upper respiratory tract infection where acute sore throat (<14 days) is the dominant symptom
AND for whom the responsible clinician is considering or has decided to prescribe an antibiotic.
Recruitment
Primary care healthcare workers will recruit participants through the recruiting sites whi
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 1 year and older 2. Consulting with symptoms of lower respiratory tract infection where cough is the predominant symptom (<28 days); or, symptoms of an upper respiratory tract infection (<14 days) where a sore throat is the dominant symptom; and where the clinician is considering/has decided to prescribe an antibiotic 3. Is able and willing to comply with all trial requirements 4. Participant or legal guardian(s) of a child is willing and able to give informed consent according to national regulations
Exclusion criteria
Exclusion criteria: 1. Patients with only nasal, ear or rhinosinusitis symptoms 2. Patients who have tested positive to SARS-CoV-2 within 28 days of onset of symptoms 3. Patients with any serious condition associated with immunocompromised (long term oral steroids or immunosuppressants, terminal cancer) 4. Patients for whom the clinician decides on immediate hospital admission 5. Patients who will not be able to participate in the study because they do not understand the local language; are terminally ill; have a serious psychiatric disorder; or judgement of the recruiting clinician deems ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary outcome: The proportion of participants being prescribed at least one antibiotic course (of any dose or duration) over 28 days from inclusion (estimating possible reduction) and time to return to usual daily activities, where returned to usual daily activity = yes (estimating non-inferiority), measured on day 1 – 14 using paper/online diary or Day 14 telephone call, and Day 28 telephone call | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Choice of antibiotic class, whether ‘delayed’ or immediate measured on day 1 – 14 using paper/online diary or day 14 telephone call, and 28 telephone call 2. Antibiotic use over 28 days after inclusion measured on day 1 – 14 using paper/online diary or day 14 telephone call, and 28 telephone call 3. Patient-reported symptoms severities, re-consultations, hospitalization, pneumonia measured on day 1 – 14 using paper/online diary or day 14 telephone call, and day 28 telephone call 4. Use of other, non-antibiotic, medication including antiviral medication, and over-the-counter treatments measured on day 1 – 14 using paper/online diary or day 14 telephone call, and day 28 telephone call 5. Responsible clinician's initial working diagnosis and antibiotic prescribing decision before test, if randomised to CA-ARTI-Dx also final decision after test, measured using online CRF at the baseline visit 6. Patient Enablement Instrument (PEI) score measured using the paper/online diary on day 1 7. Costs data: EQ5D at day 1, day 14 and day 28; time taken for testing; costs associated with subsequent help-seeking, complications, work loss and over-the-counter medication use (to be determined in close collaboration with WP5); measured using paper/online diary or day 14 telephone call, and day 28 telephone call | — |
Countries
Belgium, England, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Poland, Spain, Switzerland, United Kingdom, Wales
Outcome results
None listed