Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications

NCT03816059 | Unknown

• 1 other identifier: 20190104
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. However, 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. We 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.

Conditions

Respiratory Virus Infection; Stroke; Lung Disease; Acute Coronary Syndrome

Keywords

Respiratory virus infection; Extrapulmonary complications; Myocardial infarction; Asthma; Bronchiectasis; Chronic obstructive pulmonary disease; Cerebrovascular disease

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory viruses

  Incidence of respiratory viruses

  2 days

Secondary Outcomes (18)

• Length of hospital stay

  1 month

• Length of stay in general medical ward

  1 month

• Length of stay in high dependency unit

  1 month

• Length of stay in intensive care unit

  1 month

• Proportion of patients requiring oxygen supplementation

  1 month

Study Arms (4)

Hospitalized - ACS

Hospitalized patients with acute coronary syndrome

Diagnostic Test: Respiratory virus testing

Hospitalized - stroke

Hospitalized patients with stroke

Diagnostic Test: Respiratory virus testing

Hospitalized - chronic lung disease

Hospitalized patients with exacerbation of chronic lung disease

Diagnostic Test: Respiratory virus testing

Outpatient

Outpatients

Diagnostic Test: Respiratory virus testing

Interventions

Respiratory virus testing DIAGNOSTIC_TEST

All patients will be tested for respiratory viruses

Hospitalized - ACS; Hospitalized - chronic lung disease; Hospitalized - stroke; Outpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Hospitalized patients with acute coronary syndrome, stroke or exacerbation of underlying lung disease 2. Outpatients follow-up for chronic conditions

You may qualify if:

• Admitted to the acute medical ward of Queen Mary Hospital via the accident and emergency department
• Aged 18 years or above
• Hospitalized for less than 24 hours at the time of recruitment
• Presented with exacerbation of underlying lung disease, acute coronary syndrome or stroke
• Competent and agree to provide written informed consent

You may not qualify if:

• Admitted to any hospitals in the past 14 days
• Respiratory virus testing performed in the past 14 days
• Antiviral against respiratory virus given within the past 14 days
• Not sufficient saliva
• Aged 18 years or above
• Follow-up at out-patient clinic or at the physiotherapy department of Queen Mary Hospital
• Competent and agree to provide written informed consent
• Admitted to any hospitals in the past 14 days
• Respiratory virus testing performed in the past 14 days
• Antiviral against respiratory virus given within the past 14 days
• Onset of new respiratory or non-respiratory symptoms within the past 14 days
• Not sufficient saliva

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• 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: 28745014 RESULT

• 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: 26921740 RESULT

• 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: 29563170 RESULT

• 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: 28588283 RESULT

• 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.

  PMID: 29906597 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva specimens will be retained

MeSH Terms

Conditions

Stroke; Lung Diseases; Acute Coronary Syndrome; Myocardial Infarction; Asthma; Bronchiectasis; Pulmonary Disease, Chronic Obstructive; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Kelvin To, MD

CONTACT

(852)-22552413; kelvinto@hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 25, 2019
• Study Start: February 12, 2019
• Primary Completion: June 30, 2019
• Study Completion: April 20, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)