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
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.
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