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

• Conditions: Stroke; Acute Coronary Syndrome; Respiratory Virus Infection; Lung Disease
• Interventions: Diagnostic Test: Respiratory virus testing

• Registration Number: NCT03816059
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

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.

Previous 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.

This 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.

This 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.

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-25
• Study Start: 2019-02-12
• Primary Completion: 2019-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Study Completion: 2020-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

(For hospitalized patients)

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

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Exclusion Criteria

(For hospitalized patients)

1. Admitted to any hospitals in the past 14 days
2. Respiratory virus testing performed in the past 14 days
3. Antiviral against respiratory virus given within the past 14 days
4. Not sufficient saliva

Inclusion Criteria: (For out-patients)

1. Aged 18 years or above
2. Follow-up at out-patient clinic or at the physiotherapy department of Queen Mary Hospital
3. Competent and agree to provide written informed consent

Exclusion criteria: (For out-patients)

1. Admitted to any hospitals in the past 14 days
2. Respiratory virus testing performed in the past 14 days
3. Antiviral against respiratory virus given within the past 14 days
4. Onset of new respiratory or non-respiratory symptoms within the past 14 days
5. Not sufficient saliva

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized - stroke	Respiratory virus testing	Hospitalized patients with stroke
Hospitalized - chronic lung disease	Respiratory virus testing	Hospitalized patients with exacerbation of chronic lung disease
Hospitalized - ACS	Respiratory virus testing	Hospitalized patients with acute coronary syndrome
Outpatient	Respiratory virus testing	Outpatients

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory viruses	2 days	Incidence of respiratory viruses

Secondary Outcome Measures

Name	Time	Method
Proportion of patients admitted to coronary care unit	1 month	Proportion of patients admitted to coronary care unit
Blood culture result	3 days	The result of blood culture
Length of hospital stay	1 month	Length of hospital stay
Length of stay in general medical ward	1 month	Length of stay in general medical ward
Length of stay in high dependency unit	1 month	Length of stay in high dependency unit
Length of stay in intensive care unit	1 month	Length of stay in intensive care unit
Proportion of patients requiring oxygen supplementation	1 month	Proportion of patients requiring oxygen supplementation
Proportion of patients requiring intubation	1 month	Proportion of patients requiring intubation
Proportion of patients who die during hospitalization	1 month	Proportion of patients who die during hospitalization
Proportion of patients requiring positive pressure ventilation	1 month	Proportion of patients requiring positive pressure ventilation
Proportion of patients admitted to high dependency unit	1 month	Proportion of patients admitted to high dependency unit
Proportion of patients admitted to intensive care unit	1 month	Proportion of patients admitted to intensive care unit
Alanine aminotransferase upon admission	1 day	The level of alanine aminotransferase in blood (U/L)
White blood cell on admission	1 day	White blood cell count in blood (x 10\^9 cells/L)
Platelet count upon admission	1 day	Platelet count in blood (x 10\^9 cells/L) upon admission
Creatinine on admission	1 day	The level of creatinine in blood (umol/L) upon
Proportion of patients with pneumonia	1 month	Proportion of patients with pneumonia
Sputum culture result	3 days	The result of sputum culture

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong