Evaluation of the clinical utility of the FebriDx® test for viral and bacterial upper respiratory infection in a UK A&E department

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14380378

Enrollment

908

Registered

2021-01-27

Start date

2021-11-15

Completion date

Unknown

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute upper respiratory infections Respiratory Acute upper respiratory infections

Interventions

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 prese

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026