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NCT Number: NCT06780566

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

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Key information

Conditions

Influenza Acute Respiratory Infections (ARIs) COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Emergencies Infections Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Hospital length of stay

    Time frame: From enrollment to day 28

    Hospital length of stay in days

Secondary outcomes

  1. Neuraminidase inhibitors use

    Time frame: From enrollment to day 28

    Proportion of neuraminidase inhibitor use in patients with and without influenza

  2. Nirmatrelvir-ritonavir or molnupiravir use

    Time frame: From enrollment to day 28

    Proportion of nirmatrelvir-ritonavir or molnupiravir use in patients with and without COVID-19

  3. Median time to antiviral commencement from ED registration

    Time frame: From enrollment to day 28

    Median time to antiviral commencement from ED registration in hours

  4. Antibiotic use

    Time frame: From enrollment to day 28

    Proportion of antibiotic use in patients

  5. Median time to antibiotic commencement from ED registration

    Time frame: From enrollment to day 28

    Median time to antibiotic commencement from ED registration in hours

  6. ICU admission

    Time frame: 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

  7. ICU length of stay

    Time frame: From enrollment to day 28

    Median duration of stay in ICU and/or HDU in days

  8. Proportion of patients requiring non-invasive ventilation during their hospital stay

    Time frame: From enrollment to day 28

    Proportion of patients requiring non-invasive ventilation during their hospital stay

  9. Proportion of patients requiring mechanical ventilation during their hospital stay

    Time frame: From enrollment to day 28

    Proportion of patients requiring mechanical ventilation during their hospital stay

  10. Ventilator-free days

    Time frame: From enrollment to day 28

    Ventilator-free days

  11. 28-day All-cause mortality

    Time frame: From enrollment to day 28

    All-cause mortality

  12. In-hospital mortality

    Time frame: From enrollment to day 28

    In-hospital mortality

  13. Proportion of patients readmitted to hospital within 28 days of hospital discharge

    Time frame: From hospital discharge to day 28 after hospital discharge

    Proportion of patients readmitted to hospital within 28 days of hospital discharge

  14. Health-related quality of life

    Time frame: Day 1 ,7, 14, 28

    Health-related quality of life measured with five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)

Study contacts

Contact information is provided by the study sponsor or research team.

Joanne Leung

CONTACT

[email protected]

+852 39179715

Rex Pui Kin Lam, MBBS, MPH, FHKCEM

CONTACT

[email protected]

+852 39179413

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Acronym: RAPID-ARIED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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