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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03816059
• Other study ID #: 20190104
• Status: Recruiting
• Start date: February 12, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: March 2020
• Source: The University of Hong Kong
• Contact: Kelvin To, MD
• Phone: (852)-22552413
• Email: kelvinto[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 20, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Communicable Diseases
• Infection
• Lung Disease
• Lung Diseases
• Respiratory Virus Infection
• Stroke
• Virus Diseases

Intervention

Diagnostic Test:
• Respiratory virus testing
All patients will be tested for respiratory viruses

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & 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. Review. — View 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/ — View 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. — View 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 Mi — View 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 Resp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of respiratory viruses	Incidence of respiratory viruses	2 days
Secondary	Length of hospital stay	Length of hospital stay	1 month
Secondary	Length of stay in general medical ward	Length of stay in general medical ward	1 month
Secondary	Length of stay in high dependency unit	Length of stay in high dependency unit	1 month
Secondary	Length of stay in intensive care unit	Length of stay in intensive care unit	1 month
Secondary	Proportion of patients requiring oxygen supplementation	Proportion of patients requiring oxygen supplementation	1 month
Secondary	Proportion of patients requiring positive pressure ventilation	Proportion of patients requiring positive pressure ventilation	1 month
Secondary	Proportion of patients requiring intubation	Proportion of patients requiring intubation	1 month
Secondary	Proportion of patients admitted to intensive care unit	Proportion of patients admitted to intensive care unit	1 month
Secondary	Proportion of patients admitted to coronary care unit	Proportion of patients admitted to coronary care unit	1 month
Secondary	Proportion of patients admitted to high dependency unit	Proportion of patients admitted to high dependency unit	1 month
Secondary	Proportion of patients who die during hospitalization	Proportion of patients who die during hospitalization	1 month
Secondary	White blood cell on admission	White blood cell count in blood (x 10^9 cells/L)	1 day
Secondary	Platelet count upon admission	Platelet count in blood (x 10^9 cells/L) upon admission	1 day
Secondary	Alanine aminotransferase upon admission	The level of alanine aminotransferase in blood (U/L)	1 day
Secondary	Creatinine on admission	The level of creatinine in blood (umol/L) upon	1 day
Secondary	Blood culture result	The result of blood culture	3 days
Secondary	Sputum culture result	The result of sputum culture	3 days
Secondary	Proportion of patients with pneumonia	Proportion of patients with pneumonia	1 month

External Links

•   World Health Organization. Research needs for the battle against respiratory viruses (brave)