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

NCT ID: NCT03816059

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-12

Study Completion Date

2020-04-20

Brief Summary

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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

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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.

Conditions

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Respiratory Virus Infection Stroke Lung Disease Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospitalized - ACS

Hospitalized patients with acute coronary syndrome

Respiratory virus testing

Intervention Type DIAGNOSTIC_TEST

All patients will be tested for respiratory viruses

Hospitalized - stroke

Hospitalized patients with stroke

Respiratory virus testing

Intervention Type DIAGNOSTIC_TEST

All patients will be tested for respiratory viruses

Hospitalized - chronic lung disease

Hospitalized patients with exacerbation of chronic lung disease

Respiratory virus testing

Intervention Type DIAGNOSTIC_TEST

All patients will be tested for respiratory viruses

Outpatient

Outpatients

Respiratory virus testing

Intervention Type DIAGNOSTIC_TEST

All patients will be tested for respiratory viruses

Interventions

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Respiratory virus testing

All patients will be tested for respiratory viruses

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


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

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


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Kelvin To, MD

Role: CONTACT

(852)-22552413

Facility Contacts

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Kelvin To, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 28745014 (View on PubMed)

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.

Reference Type RESULT
PMID: 26921740 (View on PubMed)

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.

Reference Type RESULT
PMID: 29563170 (View on PubMed)

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.

Reference Type RESULT
PMID: 28588283 (View on PubMed)

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.

Reference Type RESULT
PMID: 29906597 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20190104

Identifier Type: -

Identifier Source: org_study_id

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