Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-05 @ 5:57 PM
Study NCT ID:
NCT03816059
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-04', 'size': 280119, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-01-14T20:04', 'hasProtocol': False}, {'date': '2019-01-04', 'size': 356823, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-14T20:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva specimens will be retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-20', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of respiratory viruses', 'timeFrame': '2 days', 'description': 'Incidence of respiratory viruses'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '1 month', 'description': 'Length of hospital stay'}, {'measure': 'Length of stay in general medical ward', 'timeFrame': '1 month', 'description': 'Length of stay in general medical ward'}, {'measure': 'Length of stay in high dependency unit', 'timeFrame': '1 month', 'description': 'Length of stay in high dependency unit'}, {'measure': 'Length of stay in intensive care unit', 'timeFrame': '1 month', 'description': 'Length of stay in intensive care unit'}, {'measure': 'Proportion of patients requiring oxygen supplementation', 'timeFrame': '1 month', 'description': 'Proportion of patients requiring oxygen supplementation'}, {'measure': 'Proportion of patients requiring positive pressure ventilation', 'timeFrame': '1 month', 'description': 'Proportion of patients requiring positive pressure ventilation'}, {'measure': 'Proportion of patients requiring intubation', 'timeFrame': '1 month', 'description': 'Proportion of patients requiring intubation'}, {'measure': 'Proportion of patients admitted to intensive care unit', 'timeFrame': '1 month', 'description': 'Proportion of patients admitted to intensive care unit'}, {'measure': 'Proportion of patients admitted to coronary care unit', 'timeFrame': '1 month', 'description': 'Proportion of patients admitted to coronary care unit'}, {'measure': 'Proportion of patients admitted to high dependency unit', 'timeFrame': '1 month', 'description': 'Proportion of patients admitted to high dependency unit'}, {'measure': 'Proportion of patients who die during hospitalization', 'timeFrame': '1 month', 'description': 'Proportion of patients who die during hospitalization'}, {'measure': 'White blood cell on admission', 'timeFrame': '1 day', 'description': 'White blood cell count in blood (x 10\\^9 cells/L)'}, {'measure': 'Platelet count upon admission', 'timeFrame': '1 day', 'description': 'Platelet count in blood (x 10\\^9 cells/L) upon admission'}, {'measure': 'Alanine aminotransferase upon admission', 'timeFrame': '1 day', 'description': 'The level of alanine aminotransferase in blood (U/L)'}, {'measure': 'Creatinine on admission', 'timeFrame': '1 day', 'description': 'The level of creatinine in blood (umol/L) upon'}, {'measure': 'Blood culture result', 'timeFrame': '3 days', 'description': 'The result of blood culture'}, {'measure': 'Sputum culture result', 'timeFrame': '3 days', 'description': 'The result of sputum culture'}, {'measure': 'Proportion of patients with pneumonia', 'timeFrame': '1 month', 'description': 'Proportion of patients with pneumonia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory virus infection', 'Extrapulmonary complications', 'Myocardial infarction', 'Asthma', 'Bronchiectasis', 'Chronic obstructive pulmonary disease', 'Cerebrovascular disease'], 'conditions': ['Respiratory Virus Infection', 'Stroke', 'Lung Disease', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '28745014', 'type': 'RESULT', 'citation': 'Sellers SA, Hagan RS, Hayden FG, Fischer WA 2nd. The hidden burden of influenza: A review of the extra-pulmonary complications of influenza infection. Influenza Other Respir Viruses. 2017 Sep;11(5):372-393. doi: 10.1111/irv.12470.'}, {'pmid': '26921740', 'type': 'RESULT', 'citation': 'To KK, Lau SK, Chan KH, Mok KY, Luk HK, Yip CC, Ma YK, Sinn LH, Lam SH, Ngai CW, Hung IF, Chan KH, Yuen KY. Pulmonary and extrapulmonary complications of human rhinovirus infection in critically ill patients. J Clin Virol. 2016 Apr;77:85-91. doi: 10.1016/j.jcv.2016.02.014. Epub 2016 Feb 20.'}, {'pmid': '29563170', 'type': 'RESULT', 'citation': 'Warren-Gash C, Blackburn R, Whitaker H, McMenamin J, Hayward AC. Laboratory-confirmed respiratory infections as triggers for acute myocardial infarction and stroke: a self-controlled case series analysis of national linked datasets from Scotland. Eur Respir J. 2018 Mar 29;51(3):1701794. doi: 10.1183/13993003.01794-2017. Print 2018 Mar.'}, {'pmid': '28588283', 'type': 'RESULT', 'citation': 'To KK, Lu L, Yip CC, Poon RW, Fung AM, Cheng A, Lui DH, Ho DT, Hung IF, Chan KH, Yuen KY. Additional molecular testing of saliva specimens improves the detection of respiratory viruses. Emerg Microbes Infect. 2017 Jun 7;6(6):e49. doi: 10.1038/emi.2017.35.'}, {'pmid': '29906597', 'type': 'RESULT', 'citation': 'To KKW, Yip CCY, Lai CYW, Wong CKH, Ho DTY, Pang PKP, Ng ACK, Leung KH, Poon RWS, Chan KH, Cheng VCC, Hung IFN, Yuen KY. Saliva as a diagnostic specimen for testing respiratory virus by a point-of-care molecular assay: a diagnostic validity study. Clin Microbiol Infect. 2019 Mar;25(3):372-378. doi: 10.1016/j.cmi.2018.06.009. Epub 2018 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory virus infections are one of the major causes of hospitalizations, and outbreaks of respiratory virus infection have led to severe economic loss. In addition to pulmonary complications, respiratory viruses can also lead to non-pulmonary complications.\n\nHowever, many previous studies on the complications of respiratory viruses are retrospective in nature, and therefore many patients with respiratory virus infection may not be tested. Furthermore, these studies did not take into account that respiratory viruses can be found in some asymptomatic individuals. The aim of this study is to capture the burden of respiratory viruses in patients with acute pulmonary and extrapulmonary complications. We will recruit patients admitted to our hospital with acute coronary syndrome, stroke and exacerbation of underlying lung diseases. We will collect saliva from these patients and test for respiratory viruses. As controls, we will recruit asymptomatic patients at the out-patient clinic for follow up of chronic heart, lung or neurological diseases.\n\nWe anticipate that this study will greatly enhance our understanding of the epidemiology of respiratory viruses in acutely hospitalized patients. Our findings will be important for clinicians, public health practitioners and scientists.', 'detailedDescription': 'Respiratory viruses cause severe infections, and contribute to a substantial number of hospitalizations, admission to intensive care units and deaths. Many hospitalizations due to respiratory virus infection are related to pneumonia or exacerbation of chronic lung disease. In addition, many hospitalizations are related to extrapulmonary complications, such as acute coronary syndrome or stroke.\n\nPrevious studies have reported the incidence of respiratory viruses among patients with pulmonary complications, or the association of respiratory viruses with acute coronary syndrome or stroke. However, there are several problems associated with these studies. First, many of these studies are retrospective in nature, and therefore testing was only performed in selected patients with respiratory symptoms. Hence, many patients without respiratory symptoms were not recruited. Second, respiratory virus can be detected in some asymptomatic individuals. Therefore, the presence of respiratory virus may be an incidental finding rather than the cause of the complication. Third, many studies only focus on a few respiratory viruses, especially on influenza virus.\n\nThis study aims to address these issues. The investigators propose to conduct a prospective cohort study. The investigators will recruit hospitalized adult patients with exacerbation of underlying lung disease, acute coronary syndrome or stroke. As controls, the investigators will recruit outpatients follow-up for chronic heart disease, chronic lung disease or neurological conditions. The investigators will collect saliva from study participants and perform respiratory virus testing using a multiplex PCR panel. Previous studies have shown that there is a high concordance between results from respiratory virus testing on saliva and nasopharyngeal specimens. The investigators will also use a standardized questionnaire to collect information regarding symptoms.\n\nThis study will provide accurate data on the epidemiology of respiratory viruses in pulmonary and extrapulmonary complications.These data are important for clinicians, public health practitioners and scientists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Hospitalized patients with acute coronary syndrome, stroke or exacerbation of underlying lung disease\n2. Outpatients follow-up for chronic conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (For hospitalized patients)\n\n1. Admitted to the acute medical ward of Queen Mary Hospital via the accident and emergency department\n2. Aged 18 years or above\n3. Hospitalized for less than 24 hours at the time of recruitment\n4. Presented with exacerbation of underlying lung disease, acute coronary syndrome or stroke\n5. Competent and agree to provide written informed consent\n\nExclusion Criteria: (For hospitalized patients)\n\n1. Admitted to any hospitals in the past 14 days\n2. Respiratory virus testing performed in the past 14 days\n3. Antiviral against respiratory virus given within the past 14 days\n4. Not sufficient saliva\n\nInclusion Criteria: (For out-patients)\n\n1. Aged 18 years or above\n2. Follow-up at out-patient clinic or at the physiotherapy department of Queen Mary Hospital\n3. Competent and agree to provide written informed consent\n\nExclusion criteria: (For out-patients)\n\n1. Admitted to any hospitals in the past 14 days\n2. Respiratory virus testing performed in the past 14 days\n3. Antiviral against respiratory virus given within the past 14 days\n4. Onset of new respiratory or non-respiratory symptoms within the past 14 days\n5. Not sufficient saliva'}, 'identificationModule': {'nctId': 'NCT03816059', 'briefTitle': 'Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications', 'orgStudyIdInfo': {'id': '20190104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized - ACS', 'description': 'Hospitalized patients with acute coronary syndrome', 'interventionNames': ['Diagnostic Test: Respiratory virus testing']}, {'label': 'Hospitalized - stroke', 'description': 'Hospitalized patients with stroke', 'interventionNames': ['Diagnostic Test: Respiratory virus testing']}, {'label': 'Hospitalized - chronic lung disease', 'description': 'Hospitalized patients with exacerbation of chronic lung disease', 'interventionNames': ['Diagnostic Test: Respiratory virus testing']}, {'label': 'Outpatient', 'description': 'Outpatients', 'interventionNames': ['Diagnostic Test: Respiratory virus testing']}], 'interventions': [{'name': 'Respiratory virus testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients will be tested for respiratory viruses', 'armGroupLabels': ['Hospitalized - ACS', 'Hospitalized - chronic lung disease', 'Hospitalized - stroke', 'Outpatient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kelvin To, MD', 'role': 'CONTACT', 'email': 'kelvinto@hku.hk'}, {'name': 'Kelvin To, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kelvin To, MD', 'role': 'CONTACT', 'email': 'kelvinto@hku.hk', 'phone': '(852)-22552413'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}