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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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
• Диагностический тест 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.

Первичные конечные точки

• Hospital length of stay [Срок оценки: From enrollment to day 28]

Вторичные конечные точки (12)

• Neuraminidase inhibitors use [Срок оценки: From enrollment to day 28]
• Nirmatrelvir-ritonavir or molnupiravir use [Срок оценки: From enrollment to day 28]
• Median time to antiviral commencement from ED registration [Срок оценки: From enrollment to day 28]
• Antibiotic use [Срок оценки: From enrollment to day 28]
• Median time to antibiotic commencement from ED registration [Срок оценки: From enrollment to day 28]
• ICU admission [Срок оценки: From enrollment to day 28]
• ICU length of stay [Срок оценки: From enrollment to day 28]
• Proportion of patients requiring non-invasive ventilation during their hospital stay [Срок оценки: From enrollment to day 28]
• Proportion of patients requiring mechanical ventilation during their hospital stay [Срок оценки: From enrollment to day 28]
• Ventilator-free days [Срок оценки: From enrollment to day 28]
• 28-day All-cause mortality [Срок оценки: From enrollment to day 28]
• In-hospital mortality [Срок оценки: From enrollment to day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Гонконг · 1 центр

• Accident and Emergency Department, Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT06780566 · RAPID-ARIED1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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