A study to evaluate diagnostic tests used at the point of care for improving antibiotic prescribing for patients with respiratory tract infections in primary care in Europe

Not Applicable

Completed

Conditions: Community-acquired acute respiratory tract infection
Respiratory

Registration Number: ISRCTN13336322

Lead Sponsor: niversity of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2649

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures