Clinical trial NCT06780566: Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Hospital length of stay
timeFrame: From enrollment to day 28
Secondary outcomes:
measure: Neuraminidase inhibitors use
timeFrame: From enrollment to day 28
measure: Nirmatrelvir-ritonavir or molnupiravir use
timeFrame: From enrollment to day 28
measure: Median time to antiviral commencement from ED registration
timeFrame: From enrollment to day 28
measure: Antibiotic use
timeFrame: From enrollment to day 28
measure: Median time to antibiotic commencement from ED registration
timeFrame: From enrollment to day 28
measure: ICU admission
timeFrame: From enrollment to day 28
measure: ICU length of stay
timeFrame: From enrollment to day 28
measure: Proportion of patients requiring non-invasive ventilation during their hospital stay
timeFrame: From enrollment to day 28
measure: Proportion of patients requiring mechanical ventilation during their hospital stay
timeFrame: From enrollment to day 28
measure: Ventilator-free days
timeFrame: From enrollment to day 28
measure: 28-day All-cause mortality
timeFrame: From enrollment to day 28
measure: In-hospital mortality
timeFrame: From enrollment to day 28
measure: Proportion of patients readmitted to hospital within 28 days of hospital discharge
timeFrame: From hospital discharge to day 28 after hospital discharge
measure: Health-related quality of life
timeFrame: Day 1 ,7, 14, 28
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Accident and Emergency Department, Queen Mary Hospital
state: None Selected
Study officials:
affiliation: The University of Hong Kong
name: Pui Kin Rex Lam, MBBS, MPH, FHKCEM
role: PRINCIPAL_INVESTIGATOR
References: