Respiratory infection Respiratory
Conditions
Interventions
Participants will need to provide a nose and throat swab sample. Participants will be individually randomised 1:1 to intervention (GP POCTRM test) or control (No GP POCTRM test) using an internet-base
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
12 Months to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=12 months on the day of presentation to primary care. 2. Presenting to primary care for the first time in this episode, and within 21 days of illness onset, with a Study Clinician suspected acute respiratory infection. Symptoms may include one or more of: 2.1. Sore throat 2.2. Runny nose 2.3. Earache 2.4. Cough 2.5. Sputum 2.6. Wheeze 2.7. Shortness of breath 3. Study Clinician diagnoses of an upper or lower RTI such as: 3.1. Acute otitis media 3.2. Acute sinusitis 3.3. Acute pharyngitis or tonsillitis 3.4. Sore throat 3.5. Acute laryngitis 3.6. Acute cough 3.7. Acute bronchitis 3.8. Chest infection 3.9. Acute lower RTI 3.10. Infective exacerbation of chronic lung disease e.g. asthma, chronic obstructive pulmonary disease (COPD), emphysema or bronchiectasis 4. Study Clinician or patient/parent/carer believes antibiotic treatment is, or may be, necessary (either Study Clinician or patient/parent/carer must answer "strongly agree", "agree" or “neither agree nor disagree" to the question about beliefs on use of antibiotics to treat this illness). 5. Patient/parent/carer willing and able to give informed consent 6. Patient/parent/carer willing to have a nasal and throat swab taken, or willing and able to collect, self-take and promptly return the swab to the site 7. Study Clinician and patient/parent/carer willing to wait for the POCTRM result before an antibiotic prescribing decision is made 8. Laboratory transport pick up for samples expected < 24 hours e.g. sample is expected to be ready prior to final sample collection on a Friday 9. Patient/parent/carer willing to complete Trial Diary and for outcome data to be collected from medical record
Exclusion criteria
Exclusion criteria: 1. Patient known to have cystic fibrosis 2. Patient requires hospital admission 3. Previous participation in the current RAPID-TEST trial 4. Participation in another study of RTI < = 6 weeks prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibiotic prescribing (including delayed prescribing) for a RTI at Appointment Two | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean symptom severity on Days 2 to 4; Timepoint(s): Days 2 to 4; 2. Participant Views; Timepoint(s): Day 1 and 2 Months; 3. Last day on which any symptom was recorded as “moderately bad” or worse; Timepoint(s): Up to Day 28; 4. Length of time to return to usual activities; Timepoint(s): Up to Day 28; 5. Last day prior to all symptoms recorded as zero for two consecutive days ; Timepoint(s): Up to Day 28; 6. Any new symptoms or worsening of pre-existing symptoms ; Timepoint(s): Up to Day 28; 7. Documentation of any RTI related consultation (in and out of normal office hours) after Appointment Two and =28 days, whether for the same symptoms /illness as the recruitment consultation with/out documentation that symptoms are getting worse; Timepoint(s): Up to Day 28; 8. Evidence of any hospital admission for a respiratory infection in the medical records =28 days; Timepoint(s): 2 Months; 9. Name, strength, frequency and quantity of antibiotics and antivirals prescribed after Appointment Two and =28 days; Timepoint(s): 2 Months; 10. Name of antibiotic and antiviral, and number of times per day the medicine was consumed; Timepoint(s): Up to Day 28; 11. Documentation of any consultation (in and out of normal office hours) =6 months for a RTI; Timepoint(s): 6 months; 12. Participant responses to qualitative questions; Timepoint(s): During optional interview; 13. Discrete choice experiment (DCE) survey ; Timepoint(s): During optional survey; 14. Clinician responses to qualitative questions; Timepoint(s): During optional interview; 15. Clinician DCE survey; Timepoint(s): During optional survey; 16. Clinician views; Timepoint(s): Day 1; 17. Central research laboratory POCTRM result; Timepoint(s): By end of trial; 18. Central research laboratory extended testing ; Timepoint(s): By end of trial; 19. EQ-5D-5L and EQ-5D-Y ; Timepoint(s): Up to Day 28 | — |
Countries
England, United Kingdom
Outcome results
None listed