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

NCT06780566 | Not Yet Recruiting

• 1 other identifier: RAPID-ARIED1
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; COVID-19; Acute Respiratory Infections (ARIs)

Keywords

COVID-19; Acute respiratory infections; Point-of-care testing; Polymerase Chain Reaction; Randomized controlled trial; emergency department; Influenza

Outcome Measures

Primary Outcomes (1)

• Hospital length of stay

  Hospital length of stay in days

  From enrollment to day 28

Secondary Outcomes (14)

• Neuraminidase inhibitors use

  From enrollment to day 28

• Nirmatrelvir-ritonavir or molnupiravir use

  From enrollment to day 28

• Median time to antiviral commencement from ED registration

  From enrollment to day 28

• Antibiotic use

  From enrollment to day 28

• Median time to antibiotic commencement from ED registration

  From enrollment to day 28

Study Arms (2)

Intervention Group

EXPERIMENTAL

Point-of-care PCR testing for respiratory viruses in the ED

Diagnostic Test: Point-of-care PCR testing for respiratory viruses

Control Group

OTHER

Laboratory PCR testing for respiratory viruses after admission to the hospital floor

Diagnostic Test: Laboratory PCR testing for respiratory viruses

Interventions

Point-of-care PCR testing for respiratory viruses DIAGNOSTIC_TEST

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.

Intervention Group

Laboratory PCR testing for respiratory viruses DIAGNOSTIC_TEST

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Accident and Emergency Department, Queen Mary Hospital

Hong Kong, None Selected, Hong Kong

Location

MeSH Terms

Conditions

Influenza, Human; COVID-19; Emergencies

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pui Kin Rex Lam, MBBS, MPH, FHKCEM

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rex Pui Kin Lam, MBBS, MPH, FHKCEM

CONTACT

+852 39179413; lampkrex@hku.hk

Joanne Leung

CONTACT

+852 39179715; cjojoy@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable because this is an open-label trial.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Practice

Model Details: After obtaining informed consent, each recruited participant will be given a unique participant identification number. Research team members will then use this identification number to randomise participants in a 1:1 ratio to either the intervention group or the control group. Permuted blocks of varying size (4, 6, and 8) will be generated using internet-based randomisation software

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

HK (1)