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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Influenza; Acute Respiratory Infections (ARIs)
• Intervention / Treatment: Diagnostic test: Point-of-care PCR testing for respiratory viruses; Diagnostic test: Laboratory PCR testing for respiratory viruses

• Study Type: Interventional
• Enrollment (Estimated): 1050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rex Pui Kin Lam, MBBS, MPH, FHKCEM; Phone Number: +852 39179413; Email: lampkrex@hku.hk
• Study Contact Backup: Name: Joanne Leung; Phone Number: +852 39179715; Email: cjojoy@hku.hk

Study Locations

• Hong Kong
  • None Selected
    • Hong Kong, None Selected, Hong Kong
      • Accident and Emergency Department, Queen Mary Hospital
      • Contact: Rex Lam, MBBS, MPH, FHKCEM; Phone Number: 85239179413; Email: lampkrex@hku.hk
      • Contact: Joanne Leung; Phone Number: 85239179715; Email: cjojoy@hku.hk
      • Principal Investigator: Pui Kin Rex Lam, MBBS, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Point-of-care PCR testing for respiratory viruses in the ED	Diagnostic test: Point-of-care PCR testing for respiratory viruses; A nasal swab will be collected by trained research staff in full personal protective equipment (PPE) and placed into 3 mL of viral transport medium. The sample will be immediately processed and analysed in the ED using the Xpert® Xpress SARS-CoV-2/Flu/RSV test according to the manufacturer's instructions. The results of the test will be documented in the patient's paper or electronic case notes, and the clinical team will be directly informed of all results. The participant or legal guardian who signs the consent form will also be informed of the results when appropriate.
Other: Control Group; Laboratory PCR testing for respiratory viruses after admission to the hospital floor	Diagnostic test: Laboratory PCR testing for respiratory viruses; The ordering of test for respiratory pathogens will be decided by the treating clinical team. All tests will be performed using the standard methods of the hospital laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Hospital length of stay in days	From enrollment to day 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Pui Kin Rex Lam, MBBS, MPH, FHKCEM, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Influenza; COVID-19; emergency department; Polymerase Chain Reaction; Point-of-care testing; Acute respiratory infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Emergencies; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: RAPID-ARIED1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD requires additional IRB approval because of local patient privacy ordinance.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No