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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,050 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Hospital length of stay

Hospital length of stay in days

Time frame
From enrollment to day 28

Secondary outcomes

1

Neuraminidase inhibitors use

Proportion of neuraminidase inhibitor use in patients with and without influenza

Time frame
From enrollment to day 28
2

Nirmatrelvir-ritonavir or molnupiravir use

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

Time frame
From enrollment to day 28
3

Median time to antiviral commencement from ED registration

Median time to antiviral commencement from ED registration in hours

Time frame
From enrollment to day 28
4

Antibiotic use

Proportion of antibiotic use in patients

Time frame
From enrollment to day 28

Other outcomes

Sponsors and contacts

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