Official 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
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 ofQueen Mary Hospital in Hong Kong. The investigators aim to 1) to evaluate the clinicalimpact of the routine application of point-of-care polymerase chain reaction (PCR)testing for targeted respiratory pathogens in the emergency department (ED) for adultpatients 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 ARIsduring influenza seasons or COVID-19 waves, routine point-of-care PCR test for influenzaA&B, SARS-CoV-2 and respiratory syncytial virus in the ED reduces the hospital LOSsignificantly and cost effectively compared to usual care.In total, 1,050 adult patients who are intended to be admitted to hospital with ARIs inthe ED will be recruited during influenza seasons or future waves of COVID-19 over 36months from 2025 to 2027.Participants will be randomised (1:1 ratio) into the interventional group and controlgroup. A nasal swab will be collected. In the intervention group, research staff willperform PCR test using the GeneXpert® Xpress PCR kit in the ED and communicate the testresults to the patient and the clinical team. In the control group, all microbiologytests will be determined by the clinical team, with retrospective PCR testing of thenasal swab sample after 28 days.The primary outcome is the median hospital LOS. Secondary outcomes include antivirals andantibiotics 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 (fromhealthcare provider perspective) will be conducted.Study results will provide evidence regarding the optimal PCR testing strategy in thefuture influenza seasons and COVID-19 waves.

Detailed Description

Not Provided

Not yet recruiting
Influenza
COVID-19
Acute Respiratory Infections (ARIs)

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.

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.

Eligibility Criteria

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Hong Kong
Locations

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

Investigator: Rex Lam, MBBS, MPH, FHKCEM
Contact: 85239179413
lampkrex@hku.hk

Investigator: Pui Kin Rex Lam, MBBS, MPH

Contacts

Rex Pui Kin Lam, MBBS, MPH, FHKCEM
+852 39179413
lampkrex@hku.hk

Joanne Leung
+852 39179715
cjojoy@hku.hk

Pui Kin Rex Lam, MBBS, MPH, FHKCEM, Principal Investigator
The University of Hong Kong

The University of Hong Kong
NCT Number
Keywords
Covid-19
Acute respiratory infections
Point-of-care testing
Polymerase Chain Reaction
randomized controlled trial
emergency department
Influenza
MeSH Terms
Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Emergencies