Rapid respiratory microbiological point-of-care-testing in primary care (RAPID-TEST trial)

Not Applicable

• Conditions: Respiratory infection; Respiratory

• Registration Number: ISRCTN16039192
• Lead Sponsor: niversity of Bristol

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38768129/ (added 22/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Last Update Posted: 3 June 2024
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 514

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified