Evaluation of Clinical Utility of FebriDx® In a UK A&E Department
Research type
Research Study
Full 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
IRAS ID
276038
Contact name
Mark Wilcox
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
0 years, 8 months, 30 days
Research summary
Research Summary: The test being tested in the study is the FebriDx®, which is a CE marked rapid test that can be used at the patient’s bedside to help doctors/nurses identify the cause of infection. The CE mark means that the test meets European health and safety standards and is safe for use. The FebriDx® test will determine whether the participant is suffering from a bacterial or viral respiratory infection, or no infection using a pin prick drop of blood, taken from the finger, within 10 minutes.
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. The study will be conducted within the Accident and Emergency departments of Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary and St James's University Hospital). 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 including the FebriDx® results. There will be follow up telephone calls 48 hours, 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.
We did a small version of this study before and we want to see if those results are still true. Can we make patients with suspected respiratory infections visits to A&E quicker/shorter and see if the test correctly identifies who does and does not require antibiotic treatment. We are aiming to determine if we can reduce unnecessary antibiotic prescriptions and A&E waiting times by using the test.
Summary of Results: Using antibiotics when they are not needed can lead to antimicrobial resistance, where antibiotics become less effective at treating infections. FebriDx® is a quick and safe finger-prick test that can help doctors tell whether a respiratory infection is more likely to be caused by a virus or bacteria, which may help them decide whether antibiotics are needed.
Aim
This study looked at whether using the FebriDx® test alongside normal care in UK Emergency Departments (A&E) could reduce the number of antibiotic prescriptions given to adults with respiratory infections.
Methods
The study took place in two UK Emergency Departments. Adults aged 16 years and over who had symptoms of a respiratory infection were included after giving their consent. Patients were either treated using standard care alone or standard care together with the FebriDx® test. Researchers compared antibiotic prescribing between the two groups. The study was stopped early because of the COVID-19 pandemic, so only pilot (preliminary) data were available for analysis.
Results
A total of 207 patients took part: 107 received care with the FebriDx® test and 100 received standard care alone.
Overall, there was little difference in the number of patients prescribed antibiotics in the Emergency Department. Antibiotics were prescribed to 25.5% of patients in the FebriDx® group compared with 24.7% in the standard care group.
However, among patients aged over 70 years, almost half of all antibiotic prescriptions in the FebriDx® group were given to this age group, compared with only a small proportion in the standard care group.
When patients over 70 years old were excluded from the analysis, antibiotic prescribing was lower in the FebriDx® group. In younger adults, the use of FebriDx® was associated with a 30% relative reduction in antibiotic prescribing compared with standard care alone.
Conclusion
These early findings suggest that FebriDx® could help reduce unnecessary antibiotic use in adults attending Emergency Departments with respiratory infections. The test appeared less likely to influence prescribing decisions for older patients, possibly because clinicians are more cautious about reducing antibiotic use in this age group. Larger studies are needed to confirm these findings and better understand how the test can support decision-making in elderly patients.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0070
Date of REC Opinion
29 May 2020
REC opinion
Further Information Favourable Opinion