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Ultra-rapid point-of-care testing for viruses and host response

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87771742
Enrollment
200
Registered
2023-10-20
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Respiratory viruses Infections and Infestations

Interventions

This is a pilot randomized controlled trial. As a pilot study, there is no formal sample size calculation. It is based in the Emergency Department at Southampton General Hospital. Adult patients with
however, selected participants in the point-of-care testing group may be asked to complete an optional survey and/or asked to provide an optional small blood sample, w

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Is a patient in the ED Southampton General Hospital, UHS 2. Aged >=18 years old 3. Able to be randomised within four hours of arrival in the ED 4. Has the capacity to consent to the study 5. Has at least one of the following acute respiratory symptoms: 5.1. Cough 5.2. Shortness of breath 5.3. Coryza 5.4. Sore throat 5.5. Wheeze 5.6. Fever (where not definitively explained by another cause) 5.7. Reported exacerbation of a chronic respiratory condition (e.g. asthma, COPD) (acute or worsening symptoms must be of 7 days or less duration)

Exclusion criteria

Exclusion criteria: 1. Not fulfilling all inclusion criteria 2. Declines nasal/pharyngeal swabbing or finger prick testing 3. Underlying severe bronchiectasis, cystic fibrosis, severe immune suppression, or another condition where antibiotic use is mandated according to local guidelines 4. A palliative management approach has been decided by the clinical team or appears likely to the investigator 5. Investigator discretion

Design outcomes

Primary

MeasureTime frame
The proportion of participants who received antibiotics in the Emergency Department (ED), including patients discharged from the ED with a prescription for antibiotics. Measured from electronic patient medical records up until 30 days.

Secondary

MeasureTime frame
Unless otherwise specified, all outcome measures are measured from electronic patient medical records up until 30 days: Clinical: Antibiotic-related: 1. The proportion of participants who received antibiotics in the ED 2. The proportion of patients who were discharged from the ED with an antibiotic prescription 3. The median duration of antibiotics, in days 4. The median duration of oral antibiotics, in days 5. The median duration of intravenous antibiotics, in days 6. The proportion of patients who received only a single (“stat”) dose of antibiotics 7. The proportion of patients who received antibiotics for less than 48 hours duration Other treatment-related: 1. The proportion of patients with influenza who received an influenza antiviral medication 2. The proportion of patients who did not have influenza who received antiviral medication 3. The median duration of time from arrival in ED to the first dose of influenza antiviral medication in patients, in patients with influenza and treated with an influenza antiviral medication 4. The proportion of patients with COVID-19 treated who met guidelines for treatment with dexamethasone who received dexamethasone 5. The proportion of patients with COVID-19 treated who met guidelines for treatment with a COVID-19 antiviral medication who received a COVID-19 antiviral medication Other: 1. The median time from arrival in ED to respiratory virus PCR results, in minutes 2. The proportion of patients tested by PCR for respiratory viruses 3. The proportion of patients tested by PCR by a panel of more than four respiratory viruses 4. The median duration of time to C-reactive protein results, minutes 5. The median duration of time in the ED, in minutes 6. The proportion of patients admitted to hospital from the ED 7. The proportion of patients where the treating clinician has been adherent to the treatment algorithm as guided by point-of-care testing results in the ED, within the intervention group 8. The median time from arri

Countries

England, United Kingdom

Outcome results

None listed

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