Evaluation of the clinical utility of the FebriDx® test for viral and bacterial upper respiratory infection in a UK A&E department
| ISRCTN | ISRCTN14380378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14380378 |
| IRAS number | 276038 |
| Secondary identifying numbers | CPMS 45068, IRAS 276038 |
- Submission date
- 22/01/2021
- Registration date
- 27/01/2021
- Last edited
- 03/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Viral and bacterial respiratory infections (coughs and colds) represent a major source of morbidity, mortality and healthcare burden.
Because bacterial and viral infections are characterised by similar signs and symptoms, it can be difficult to distinguish between these causes. To aid clinicians in differentiating between infections caused by bacteria and viruses, new biomarkers are being investigated.
The test being tested in the study is the FebriDx®, which is a CE marked rapid point of care test to aid clinical diagnosis of viral or bacterial acute upper respiratory infections. This study aims to determine the extent of the health economic gains achieved by using FebriDx® in terms of both reduced waiting times and reductions in unnecessary antibiotic prescriptions.
Who can participate?
All patients aged 16 years or older presenting to the Accident and Emergency department with symptoms of respiratory infection are eligible for inclusion into the trial.
What does the study involve?
Participants will be enrolled in the study for 14 days. They will be enrolled into the study and then be allocated to standard care or management by the FebriDx® results. There will be follow up telephone calls 7 and 14 days later to ask about the symptoms, whether the participant has visited the Accident and Emergency department again and have they received any antibiotics. At the end of the telephone call on day 14 the participant will have completed the study.
What are the possible benefits and risks of participating?
Benefits: There may be no benefits to taking part in this study and that is why we are doing this work. Although the test has already been tested for accuracy and has a CE mark (enabling us to use for patient testing), we do not know the impact of this test on antibiotic prescribing and this is why it is important to conduct the research.
We anticipate the biggest benefit from the study will be to patients in the future. The information we get from this trial may help us treat other patients more effectively in the future.
Risks: If you are in the new test group you will have a small pin prick on one finger to enable us to collect one drop of blood, which may cause a very small amount of mild discomfort.
There is a very small chance that the test will say you do not need antibiotics when you do. That is why the people treating you are not relying on the test alone. If other tests and measurements suggest you need antibiotics these will be given. If you are discharged, we will telephone you after 48 hours to check that you are feeling better and not feeling any worse. If you are not feeling any better, you will be asked to return to A&E where you will be seen again.
Where is the study run from?
Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary and St James's University Hospital) (UK).
When is the study starting and how long is it expected to run for?
December 2019 to November 2021
Who is funding the study?
The Jon Moulton Charity Trust (Guernsey, UK)
Who is the main contact?
Dr Kerrie Davies, Kerrie.davies@nhs.net
Contact information
Scientific
Healthcare Associated Infection Research Group
Microbiology
Old Medical School
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
 ORCID ID |
0000-0001-6862-5355 |
|---|---|
| Phone | No telephone contact available |
| Kerrie.davies@nhs.net |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective, pragmatic study to evaluate the clinical utility of FebriDx® in determining whether or not patients presenting to a UK accident and emergency department with symptoms of acute respiratory infection require antibiotic treatment |
| Study objectives | Does the result of the FebriDx® test reduce the proportion of inappropriate antibiotic prescribing in the Accident and Emergency department? |
| Ethics approval(s) | Approved 06/07/2020, York and Humber Sheffield Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8222; sheffield.rec@hra.nhs.uk), ref: 20/YH/0070 |
| Health condition(s) or problem(s) studied | Acute upper respiratory infections |
| Intervention | All patients attending the Accident and Emergency department (A&E) at St James’s University Hospital, Leeds Teaching Hospitals NHS Trust (LTHT), will be invited to take part in the study if they present with clinical symptoms of coughs and colds. Following informed consent participants will be allocated to receive standard care or to be managed according to the FebriDx® test results. All participants will be asked to provide a short medical and symptom history and, if not already taken as part of the triage process, patients will have vital measurements recorded (blood pressure, pulse and temperature). Participants will be randomly allocated to standard care (control group) or FebriDx® management (implementation group) according to sequential cohort blocks. Participants allocated to FebriDx® management will have a small volume of finger-stick blood collected for the test, completed by a trained healthcare professional. Once the test has been completed the results will be recorded and provided to the treating clinician at the same time as routine test results. The FebriDx® result will not be used in isolation but as a clinical decision making aid. All participants will be followed up via a pre-arranged telephone clinic at 7 and 14 days post initial A&E presentation to collect data on symptoms, access to healthcare services (GP/A&E) and new antibiotic prescriptions. At the end of the 14 day follow up visit, participants will have completed the study. Routinely, patients arriving by ambulance or self-presenting to the accident and emergency department with suspected respiratory infection are booked in at reception and undergo a vet process by a registered nurse to identify those who are particularly unwell. If that is not the case, the patient may streamed to the rapid assessment unit or majors in the A&E depending on need. A more comprehensive nurse assessment takes place where the patient may have an ECG, blood tests, a peak flow and a chest xray. The patient is then seen by an A&E clinician (Doctor, Advanced Practitioner or Physician Associate) and a management plan developed. This may result in discharge with advice, with antibiotics or admission onto the Clinical Decision Unit or an inpatient bed. Participants allocated to FebriDx® management will have a small volume of finger-stick blood (one drop) collected for the test, completed by a trained healthcare professional (part of the research team). Once the test has been completed the results will be recorded and fed back to the clinician; treatment will be guided accordingly by the test results. FebriDx® results would not be used if the test indicated the patient did not have a bacterial infection but there was overriding clinical suspicion that the participant was suffering from a bacterial infection. In this instance it would not be appropriate to withhold antibiotics. This would be recorded as a protocol deviation and analysed as such. In order to demonstrate a reduction in the number of antibiotic prescriptions in Accident and Emergency departments and to allow for patients failing to complete their time in the study we need to recruit 908 patients. 454 will be allocated to standard care and 454 to testing using the new test (FebriDx®). |
| Intervention type | Other |
| Primary outcome measure | 1. Number of inappropriate antibiotic prescriptions given in the Accident and Emergency department measured at day 0 2. Number of unscheduled follow-up visits to GP surgery/afterhours/A&E within 7 days measured at day 7 follow up telephone call 3. Number of disease specific complications experienced by the patients such as mastoiditis, peritonsillar abscess, sepsis, orbital abscess, extradural and subdural abscesses, meningitis and pan-sinusitis within 14 days measured at day 14 follow up telephone call 4. Number of clinician consultations/associated healthcare costs measured at days 0 - 14, initial presentation and follow up telephone calls on day 7 and day 14 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2019 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 908; UK Sample Size: 908 |
| Key inclusion criteria | 1. Participant reports a temperature of >=37.5 degrees C in the last 3 days or exhibited at visit 2. Participant reports symptoms within the last 7 days that are indicative of a new, acute respiratory infection in the opinion of the research team. (Symptoms can include but are not limited to: runny nose, nasal congestion, sore throat, new cough, hoarse voice and shortness of breath). 3. Participant is aged >= 16 years 4. Capacity to consent 5. Ability to understand English |
| Key exclusion criteria | 1. The participant is immunocompromised or taking chemotherapy, oral steroids, or interferon 2. The participant is currently prescribed antibiotics, antivirals or had a recent live vaccine 3. The participant has a pyrexia which has lasted more than 3 days prior to the visit to accident and emergency department |
| Date of first enrolment | 15/11/2021 |
| Date of final enrolment | 31/01/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Great George Street
Leeds
LS1 3EX
United Kingdom
Beckett Street
West Yorkshire
Leeds
LS9 7TF
United Kingdom
Sponsor information
University/education
NHS Research Ethics Officer
Address Faculty Research Office
Room 9.29, Level 9, Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
| Phone | +44 (0)1133437587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The study results will be submitted for presentation at two international conferences, one highlighting the study results to the microbiology and infectious disease community, with another focussed on the Health Economic evaluations. Dissemination and engagement with the wider international health provider community is essential to maximise outputs from the study; if positive they could influence changes at other trusts, if negative they prevent repetition of work at other trusts which is both unethical (in terms of recruiting patients to a study where the conclusion are already known) and costly (in terms of resources and staff). The results will also be written into two manuscripts and submitted to scientific peer reviewed journals, with open access. It is also important to disseminate results directly to the accident and emergency departments within the UK; with this in mind a one page infographic will be developed with the University of Leeds print Copy Bureau to be disseminated to all UK trusts. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/11/2021: The study contact has been updated and the plain English summary has been updated accordingly.
20/10/2021: The recruitment start date has been changed from 01/10/2021 to 15/11/2021.
22/01/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)
