Ultra-Rapid POCT for Viruses and Host Response (UltraPOC) v1.0
Research type
Research Study
Full title
The clinical impact of ultra-rapid syndromic molecular point-of-care testing for respiratory viruses combined with finger-prick host response testing in adults presenting to the Emergency Department with Acute Respiratory Illness: A pilot randomised controlled trial (UltraPOC)
IRAS ID
330292
Contact name
Tristan Clark
Contact email
Sponsor organisation
R&D, University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
We aim to evaluate the potential clinical impact of ultra-rapid syndromic molecular point-of-care testing for respiratory viruses combined with host response biomarker testing compared to standard clinical care in patients presenting to the Emergency Department with acute respiratory illness in a pilot study and therefore to inform the design of a subsequent full randomised controlled trial.
Antibiotic use is the primary outcome as reducing uneccesary antibiotic use is a national and international priority to stop antimicrobial resistance.
Adult patients with acute respiratory illness in Southampton General Hospital’s Emergency Department will be identified and assessed for eligibility for this trial.
Potential participants would have been seen and assessed by the triage nurse but might not have been fully treated by their clinician.
Eligible and consenting participants will be randomised (1 to 1) to be in either the point-of-care testing group (intervention) or the standard clinical care group (control group).
Participants in the point-of-care testing group will receive an ultra-rapid syndromic respiratory virus PCR test by nasopharyngeal swab (15mins), a finger-prick anti-viral host response protein MxA test (10mins), and a finger-prick CRP test (4mins).
The results of all three tests will be entered into the patient’s notes alongside an algorithm recommending, considering, or not recommending antibiotic use.
Participants in the control group will be asked for a nasopharyngeal swab that will be frozen and tested at least 30 days after enrolment.
All necessary patient participation is completed in a single encounter; however, selected participants may be asked to complete an optional survey and/or asked to provide an optional small blood sample, within 24 hours of randomisation if they are still in hospital.
Addtionally, we shall survey Emergency Department personnel's attitudes towards point-of-care testing, and the point-of-care test operators, to assist in understanding how to improve the design of the subsequent full randomised controlled trial.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0294
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion