Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled efficacy trial with internal pilot and qualitative and quantitative investigation of microbial, behavioural and antibiotic mechanisms (the RAPID-TEST RCT)
University of Bristol
Duration of Study in the UK
2 years, 1 months, 30 days
This is a multi-centre, individually randomised controlled trial to determine whether respiratory microbiological point-of-care-tests (POCTRM) reduce same day antibiotic prescribing and modify clinician and patient beliefs about the need for antibiotics. The trial aims to recruit 514 participants from up to 16 GP practices across England.
Patients aged ≥12 months presenting to their GP practice for a suspected respiratory infection where the Study Clinician and/or participant believe antibiotic treatment is, or may be, necessary will be invited to take part. A swab of the nose and throat will be taken from participants using standard kits provided.
Participants will be individually randomised 1:1 to intervention (GP POCTRM Test) or control (No GP POCTRM Test). For participants randomised to GP POCTRM Test, a portion of the swab sample will be analysed immediately at the GP practice using the POCTRM machine. The time for processing one swab to results being available is approximately 1 hour.
The remaining swab sample from participants in the intervention arm and the whole swab sample from participants in the control arm will be transferred within 24 hours to the central research laboratory. The central lab will repeat testing using the POCTRM machine and will also conduct extended testing for respiratory viruses and bacteria.
The Study Clinician will be informed of the participant’s allocated group immediately after randomisation. For participants randomised to GP POCTRM Test, the Study Clinician will need to wait to receive the POCTRM result before deciding whether any treatment is required. For participants randomised to No GP POCTRM Test, decisions can proceed immediately.
Participants will be asked to complete a Trial Diary for up to 28 days or until symptoms resolve, whichever is sooner. They will also be sent a 2-month follow up questionnaire.
North West - Preston Research Ethics Committee
Date of REC Opinion
11 Oct 2022
Further Information Favourable Opinion