RAPID-TEST
Research type
Research Study
Full title
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)
IRAS ID
299674
Contact name
Alastair Hay
Contact email
Sponsor organisation
University of Bristol
ISRCTN Number
ISRCTN16039192
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
Summary of Research
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.
Summary of Results
: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Frapidtest.blogs.bristol.ac.uk%252Fresults-summary%252F%2FNBTI%2FiOnGAQ%2FAQ%2Fa8713e46-eb20-4990-9b06-3402528a640a%2F3%2F2R8eyS1j_I&data=05%7C02%7Cpreston.rec%40hra.nhs.uk%7Cff34772b527a4a96739d08dee987475d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639204964410272186%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EpE%2F36L7jevUHvEykikVkp27iomuPczLDbvQlrdY%2Fow%3D&reserved=0Why do we need this research?
Antibiotics are prescribed for over 50% of respiratory tract infections (RTIs) in primary care, despite good evidence most patients do not benefit.
Rapid microbiological point-of-care tests (POCTRM) could improve antibiotic prescribing for RTI’s in primary care by detecting if microbes are present in respiratory tract samples.What is the RAPID-TEST trial?
We asked the question “Does point of care testing reduce same-day antibiotic prescribing?”
Point of care testing is medical diagnostic testing performed at or near the site of patient care (in this case at the GP practice), which allows for rapid results and immediate clinical decision making.
16 GP practices in the South West were involved
552 patients took part between 02.12.2022 and 30.04.2024 In our study we used the ‘The BioMerieux BioFire FilmArray Torch 1 POCT’, which works by detecting the presence or absence of 23 upper respiratory microbes: 19 viruses and four ‘atypical’ bacteria. It does not test for ‘typical’ bacteria.
Half of patients were randomised to receive POCTRM informed care (n=276) and the other half received usual care (n=276).The clinicians responsible for the care of participants included GPs (42%), nurses (39%), paramedics (12%) and physician assistants (6%). Most (86%) participants were adults, most (66%) female, and most (94%) described their ethnicity as white.
The primary outcome ( whether antibiotics were prescribed on the same day) were available for 552 (100%) participants.
Valid POCTRM results were available in 99% of participants, with half of samples not detecting any microbe. At least one virus, and at least one atypical bacterium, were detected in 40% and 7% of samples respectively.
Did using POCT change antibiotic prescribing?
Using POCT did not change antibiotic prescribing overall. 45% of patients in both groups were prescribed same day antibiotics.
Antibiotic prescribing between days two and 28 was also similar between the groups, and there was no difference in participant reported antibiotic consumption from days one to 28.
Antibiotic prescribing was reduced by 14% in those with chronic lung diseases in the intervention group (those who received the POCT).
Antibiotic prescribing decreased in patients where the POCT detected a virus.
Antibiotic prescribing increased in patients where the POCT did not detect a virus.Did using the POCT affect patient symptoms?
There was no evidence of a difference in symptom severity on days 2 to 4 after the consultation.
There was no evidence of a difference in overall symptom duration.
There was no evidence of a difference in the duration of moderately bad or worse symptoms.
There was no evidence of a difference in the time taken to return to usual activities.
There was no evidence of a difference in the proportion of people experiencing new or worsening symptoms.Did using POCT affect patient’s consulting behaviours?
There was no evidence of a difference in further consultations for respiratory infections (24% in the intervention group and 21% in the usual care group) Two patients were hospitalised for a respiratory tract infection in the intervention group, and one in the control group.
There was no evidence that use of the POCTRM led to an increase in: observed healthcare seeking, either for the index illness or in the subsequent 6 months or intended participant healthcare seeking behaviour.What did patients think about the POCT?
In general, participants viewed POCTRMs favourably. Patients believed POCTRMs reduced diagnostic uncertainty but emphasised that POCTRMs should be used alongside clinical judgement. For some, additional information from POCTRMs created positive outcome expectancies and reduced the perception that antibiotics were necessary. Others felt invalidated by POCTRM’ results or believed further support was necessary to understand when antibiotics were needed and how they could manage symptoms.
REC name
North West - Preston Research Ethics Committee
REC reference
22/NW/0294
Date of REC Opinion
11 Oct 2022
REC opinion
Further Information Favourable Opinion