Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
Study NCT ID:
NCT06780566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not applicable because this is an open-label trial.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1050}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'From enrollment to day 28', 'description': 'Hospital length of stay in days'}], 'secondaryOutcomes': [{'measure': 'Neuraminidase inhibitors use', 'timeFrame': 'From enrollment to day 28', 'description': 'Proportion of neuraminidase inhibitor use in patients with and without influenza'}, {'measure': 'Nirmatrelvir-ritonavir or molnupiravir use', 'timeFrame': 'From enrollment to day 28', 'description': 'Proportion of nirmatrelvir-ritonavir or molnupiravir use in patients with and without COVID-19'}, {'measure': 'Median time to antiviral commencement from ED registration', 'timeFrame': 'From enrollment to day 28', 'description': 'Median time to antiviral commencement from ED registration in hours'}, {'measure': 'Antibiotic use', 'timeFrame': 'From enrollment to day 28', 'description': 'Proportion of antibiotic use in patients'}, {'measure': 'Median time to antibiotic commencement from ED registration', 'timeFrame': 'From enrollment to day 28', 'description': 'Median time to antibiotic commencement from ED registration in hours'}, {'measure': 'ICU admission', 'timeFrame': 'From enrollment to day 28', 'description': 'Proportion of patients requiring admission to an intensive care unit (ICU) or a high dependency unit (HDU), censored at 28 days post-enrolment'}, {'measure': 'ICU length of stay', 'timeFrame': 'From enrollment to day 28', 'description': 'Median duration of stay in ICU and/or HDU in days'}, {'measure': 'Proportion of patients requiring non-invasive ventilation during their hospital stay', 'timeFrame': 'From enrollment to day 28', 'description': 'Proportion of patients requiring non-invasive ventilation during their hospital stay'}, {'measure': 'Proportion of patients requiring mechanical ventilation during their hospital stay', 'timeFrame': 'From enrollment to day 28', 'description': 'Proportion of patients requiring mechanical ventilation during their hospital stay'}, {'measure': 'Ventilator-free days', 'timeFrame': 'From enrollment to day 28', 'description': 'Ventilator-free days'}, {'measure': '28-day All-cause mortality', 'timeFrame': 'From enrollment to day 28', 'description': 'All-cause mortality'}, {'measure': 'In-hospital mortality', 'timeFrame': 'From enrollment to day 28', 'description': 'In-hospital mortality'}, {'measure': 'Proportion of patients readmitted to hospital within 28 days of hospital discharge', 'timeFrame': 'From hospital discharge to day 28 after hospital discharge', 'description': 'Proportion of patients readmitted to hospital within 28 days of hospital discharge'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Day 1 ,7, 14, 28', 'description': 'Health-related quality of life measured with five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Acute respiratory infections', 'Point-of-care testing', 'Polymerase Chain Reaction', 'Randomized controlled trial', 'emergency department', 'Influenza'], 'conditions': ['Influenza', 'COVID-19', 'Acute Respiratory Infections (ARIs)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nIn 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.\n\nParticipants 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.\n\nThe 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.\n\nIntention-to-treat analysis (superiority framework) and cost-effectiveness analysis (from healthcare provider perspective) will be conducted.\n\nStudy results will provide evidence regarding the optimal PCR testing strategy in the future influenza seasons and COVID-19 waves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years or above\n* 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.)\n* Respiratory symptoms present ≤10 days before admission to hospital\n* No prior treatment with antibiotics or antivirals in the previous 14 days\n\nExclusion Criteria:\n\n* Refusal of nasal or pharyngeal swabbing\n* Refusal of informed consent\n* Previously included in the study and re-presentation within 28 days of hospital discharge\n* A prior positive test by antigen test or other PCR test for COVID-19 or influenza before ED presentation\n* 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).'}, 'identificationModule': {'nctId': 'NCT06780566', 'acronym': 'RAPID-ARIED', 'briefTitle': 'Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department Trial', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department (RAPID-ARIED) Trial', 'orgStudyIdInfo': {'id': 'RAPID-ARIED1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Point-of-care PCR testing for respiratory viruses in the ED', 'interventionNames': ['Diagnostic Test: Point-of-care PCR testing for respiratory viruses']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Laboratory PCR testing for respiratory viruses after admission to the hospital floor', 'interventionNames': ['Diagnostic Test: Laboratory PCR testing for respiratory viruses']}], 'interventions': [{'name': 'Point-of-care PCR testing for respiratory viruses', 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Intervention Group']}, {'name': 'Laboratory PCR testing for respiratory viruses', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'None Selected', 'country': 'Hong Kong', 'contacts': [{'name': 'Rex Lam, MBBS, MPH, FHKCEM', 'role': 'CONTACT', 'email': 'lampkrex@hku.hk', 'phone': '85239179413'}, {'name': 'Joanne Leung', 'role': 'CONTACT', 'email': 'cjojoy@hku.hk', 'phone': '85239179715'}, {'name': 'Pui Kin Rex Lam, MBBS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Accident and Emergency Department, Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Rex Pui Kin Lam, MBBS, MPH, FHKCEM', 'role': 'CONTACT', 'email': 'lampkrex@hku.hk', 'phone': '+852 39179413'}, {'name': 'Joanne Leung', 'role': 'CONTACT', 'email': 'cjojoy@hku.hk', 'phone': '+852 39179715'}], 'overallOfficials': [{'name': 'Pui Kin Rex Lam, MBBS, MPH, FHKCEM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD requires additional IRB approval because of local patient privacy ordinance.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor of Practice', 'investigatorFullName': 'Lam Pui Kin', 'investigatorAffiliation': 'The University of Hong Kong'}}}}