Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department Trial

Not Applicable

Not yet recruiting

• Conditions: Influenza; COVID-19; Acute Respiratory Infections (ARIs)

• Registration Number: NCT06780566
• Lead Sponsor: The University of Hong Kong

Brief Summary

The RAPID-ARIED Trial is a pragmatic, single-centre, parallel group, open-label, randomised controlled trial to be conducted in the Accident and Emergency Department of Queen Mary Hospital in Hong Kong. The investigators aim to 1) to evaluate the clinical impact of the routine application of point-of-care polymerase chain reaction (PCR) testing for targeted respiratory pathogens in the emergency department (ED) for adult patients with acute respiratory infections (ARIs) on the hospital length of stay (LOS), antiviral and antibiotic use during influenza seasons or future waves of COVID-19; and 2) to conduct a health economic analysis of such a strategy.

The investigators hypothesise that in adult patients hospitalised from the ED for ARIs during influenza seasons or COVID-19 waves, routine point-of-care PCR test for influenza A\&B, SARS-CoV-2 and respiratory syncytial virus in the ED reduces the hospital LOS significantly and cost effectively compared to usual care.

In total, 1,050 adult patients who are intended to be admitted to hospital with ARIs in the ED will be recruited during influenza seasons or future waves of COVID-19 over 36 months from 2025 to 2027.

Participants will be randomised (1:1 ratio) into the interventional group and control group. A nasal swab will be collected. In the intervention group, research staff will perform PCR test using the GeneXpert® Xpress PCR kit in the ED and communicate the test results to the patient and the clinical team. In the control group, all microbiology tests will be determined by the clinical team, with retrospective PCR testing of the nasal swab sample after 28 days.

The primary outcome is the median hospital LOS. Secondary outcomes include antivirals and antibiotics use and administration time, mortality, and quality-adjusted life year, assessed using the EQ-5D-5L questionnaire.

Intention-to-treat analysis (superiority framework) and cost-effectiveness analysis (from healthcare provider perspective) will be conducted.

Study results will provide evidence regarding the optimal PCR testing strategy in the future influenza seasons and COVID-19 waves.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-30
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

• Adult patients aged 18 years or above
• Intended for admission to hospital with acute respiratory illness (defined as a provisional diagnosis of pneumonia, bronchitis, influenza-like illness, acute exacerbation of chronic obstructive pulmonary disease, asthma or bronchiectasis.)
• Respiratory symptoms present ≤10 days before admission to hospital
• No prior treatment with antibiotics or antivirals in the previous 14 days

Exclusion Criteria

• Refusal of nasal or pharyngeal swabbing
• Refusal of informed consent
• Previously included in the study and re-presentation within 28 days of hospital discharge
• A prior positive test by antigen test or other PCR test for COVID-19 or influenza before ED presentation
• Exposure to FluMist® or other similar live attenuated influenza vaccines within 1 month (because such exposures may lead to a false positive PCR test result with the nasal swab sample).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	From enrollment to day 28	Hospital length of stay in days

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	From enrollment to day 28	In-hospital mortality
Proportion of patients readmitted to hospital within 28 days of hospital discharge	From hospital discharge to day 28 after hospital discharge	Proportion of patients readmitted to hospital within 28 days of hospital discharge
Health-related quality of life	Day 1 ,7, 14, 28	Health-related quality of life measured with five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Antibiotic use	From enrollment to day 28	Proportion of antibiotic use in patients
Neuraminidase inhibitors use	From enrollment to day 28	Proportion of neuraminidase inhibitor use in patients with and without influenza
Nirmatrelvir-ritonavir or molnupiravir use	From enrollment to day 28	Proportion of nirmatrelvir-ritonavir or molnupiravir use in patients with and without COVID-19
Median time to antiviral commencement from ED registration	From enrollment to day 28	Median time to antiviral commencement from ED registration in hours
Median time to antibiotic commencement from ED registration	From enrollment to day 28	Median time to antibiotic commencement from ED registration in hours
ICU admission	From enrollment to day 28	Proportion of patients requiring admission to an intensive care unit (ICU) or a high dependency unit (HDU), censored at 28 days post-enrolment
ICU length of stay	From enrollment to day 28	Median duration of stay in ICU and/or HDU in days
Proportion of patients requiring non-invasive ventilation during their hospital stay	From enrollment to day 28	Proportion of patients requiring non-invasive ventilation during their hospital stay
Proportion of patients requiring mechanical ventilation during their hospital stay	From enrollment to day 28	Proportion of patients requiring mechanical ventilation during their hospital stay
Ventilator-free days	From enrollment to day 28	Ventilator-free days
28-day All-cause mortality	From enrollment to day 28	All-cause mortality

Trial Locations

Locations (1)

Accident and Emergency Department, Queen Mary Hospital; 🇭🇰 Hong Kong, None Selected, Hong Kong