Rapid respiratory microbiological point-of-care-testing in primary care (RAPID-TEST trial)
| ISRCTN | ISRCTN16039192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16039192 |
| IRAS number | 299647 |
| Secondary identifying numbers | CPMS 53931, NIHR131758, IRAS 299674 |
- Submission date
- 21/10/2022
- Registration date
- 08/11/2022
- Last edited
- 25/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
In the UK, GPs treat over 50% of respiratory tract infections (RTIs) with antibiotics despite strong evidence that the majority of patients do not benefit. Antibiotics can have side effects and unnecessary overuse leads to antimicrobial resistance which is a top 10 threat to global public health. One potential solution is use of point-of care-tests (POCT) which are medical tests conducted at the time and place of patient care. Rapid respiratory point-of-care-tests (POCTRM) could be used to inform antibiotic prescribing decisions.
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.
Who can participate?
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.
What does the study involve?
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.
What are the possible benefits and risks of participating?
For participants in the group allocated to receiving the POCTRM results, those results may help the GP decide whether an antibiotic is required to treat their respiratory tract infection. Some people find taking part in research rewarding and may benefit from the extra contact from being part of the trial. Involvement in the trial may help to inform future treatment recommendations for patients with respiratory tract infections.
Participating in this trial will mean taking time out of normal activities to allow the trial research team to collect information from participants about their respiratory tract infection. The trial research team will also need to collect information about participant’s views at three separate points during the day that they present to their GP. Participants may need to wait longer than usual for the GP to make a decision about whether any antibiotic treatment will be prescribed. Participants will also need to spend a couple of minutes every day completing the Trial Diary for up to 28 days and a couple of minutes completing the 2-Month Questionnaire.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
April 2022 to May 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Prof. Alastair Hay, rapidtest-study@bristol.ac.uk
Contact information
Scientific
Population Health Sciences
Bristol Medical School
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0003-3012-375X |
|---|---|
| Phone | +44 1179287376 |
| rapidtest-study@bristol.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific 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) |
| Study acronym | RAPID-TEST |
| Study hypothesis | Use of a rapid respiratory microbiological point-of-care-test (POCTRM), for suspected respiratory tract infections (RTIs) in primary care, will reduce same-day antibiotic prescribing. |
| Ethics approval(s) | Approved 11/10/2022, (), ref: 22/NW/0294 |
| Condition | Respiratory infection |
| Intervention | 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-based randomisation system developed and maintained by Sealed Envelope™. For participants randomised to the GP POCTRM Test group, a portion of their swab sample will be analysed immediately using the BioFire® FilmArray® Torch 1 machine. The remaining swab sample from participants in the GP POCTRM Test group and the whole swab sample from participants in the No GP POCTRM Test group will be transferred within 24 hours to the central research laboratory. For participants randomised to GP POCTRM Test, the Study Clinician will wait to receive the result of the POCTRM before deciding whether any antibiotic treatment is required. For participants randomised to No GP POCTRM Test, a decision on whether antibiotic treatment is required can be made immediately. |
| Intervention type | Other |
| Primary outcome measure | Antibiotic prescribing (including delayed prescribing) for a RTI at Appointment Two |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2022 |
| Overall study end date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Months |
| Sex | Both |
| Target number of participants | Planned Sample Size: 514; UK Sample Size: 514 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 14/11/2022 |
| Recruitment end date | 30/09/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bristol
BS4 4HU
United Kingdom
Whatley Road
Clifton
Bristol
BS8 2PU
United Kingdom
Pudding Pie Lane
Langford
Bristol
BS40 5EL
United Kingdom
9 Chesterton Lane
Cirencester
GL7 1XG
United Kingdom
Clevedon
BS21 6DG
United Kingdom
Thornbury
Bristol
BS35 1DP
United Kingdom
Bristol
BS13 0JP
United Kingdom
Nailsworth
Stroud
GL6 0DQ
United Kingdom
Bath
BA2 3HT
United Kingdom
Warmley
North Common
Bristol
BS30 5JZ
United Kingdom
Quay Street
Gloucester
GL1 2TZ
United Kingdom
Chippenham
SN15 1HP
United Kingdom
Highlands Lane
Weston-super-mare
BS24 7DX
United Kingdom
2 Haven View
Portishead
Bristol
BS20 7QA
United Kingdom
10 Waterloo Road
Radstock
BA3 3EP
United Kingdom
21 West Walk
Bristol
BS37 4AX
United Kingdom
Sponsor information
University/education
Research & Enterprise Division
Second Floor, Augustines Courtyard
Orchard Lane
Bristol
BS1 5DS
England
United Kingdom
| Phone | +44 117 4556247 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The aim will be to publish our primary manuscript in a high impact medical journal, and present our findings at medical conferences. We will also write a full report for the NIHR. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 04/10/2022 | 07/11/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 20/05/2024 | 22/05/2024 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 02/09/2024 | 10/09/2024 | No | No |
| Protocol file | version 3.0 | 06/03/2023 | 25/10/2024 | No | No |
| Protocol file | version 4.0 | 01/02/2024 | 25/10/2024 | No | No |
| Protocol file | version 5.0 | 05/07/2024 | 25/10/2024 | No | No |
| Protocol file | version 6.0 | 12/09/2024 | 25/10/2024 | No | No |
Additional files
- 42638 Protocol v2.0 04Oct2022.pdf
- ISRCTN16039192_SAP_v1.0_02Sept2024.pdf
- ISRCTN16039192 RAPID TEST Protocol V3.0 06Mar23.pdf
- ISRCTN16039192 RAPID TEST Protocol V4.0 01FEB2024_signed.pdf
- ISRCTN16039192 RAPID TEST Protocol V5.0 05JUL2024_signed.pdf
- ISRCTN16039192 RAPID TEST Protocol V6.0 12SEPT2024_signed_final.pdf
Editorial Notes
25/10/2024: Uploaded protocols v3.0 - v6.0 (not peer-reviewed) as additional files.
10/09/2024: The following changes were made:
1. Statistical analysis plan added.
2. Clevedon Medical Centre, Streamside Surgery, Hartwood Healthcare, Prices Mill Surgery, Heart of Bath, Close Farm Surgery, Severnside Medical Practice, Hathaway Surgery, Stafford Medical Group, Harbourside Family Practice, Hope House Surgery, and West Walk Surgery were added as study participating centres.
22/05/2024: Publication reference added.
21/10/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
