Respiratory Virus InfectionNCT03816059
Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications
An observational study of Respiratory Virus Infection and Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Virus Infection, Stroke, Lung Disease
- What is being tested?
- Respiratory virus testing
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Feb 2019to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Hospitalized patients with acute coronary syndrome, stroke or exacerbation of underlying lung disease 2. Outpatients follow-up for chronic conditions
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Admitted to any hospitals in the past 14 days
- Respiratory virus testing performed in the past 14 days
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Kelvin To, MD, kelvinto@hku.hk
Kelvin To, MD
About this study
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.
Read the 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.
- Being tested
- Respiratory virus testing
- Keywords
- Respiratory virus infection, Extrapulmonary complications, Myocardial infarction, Asthma, Bronchiectasis, Chronic obstructive pulmonary disease, Cerebrovascular disease
- Medical subject headings
- Stroke, Lung Diseases, Acute Coronary Syndrome, Myocardial Infarction, Asthma, Bronchiectasis, Pulmonary Disease, Chronic Obstructive, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory virus testingDiagnostic test
All patients will be tested for respiratory viruses
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized - ACS | Hospitalized patients with acute coronary syndrome Receives: Diagnostic Test: Respiratory virus testing | |
| Hospitalized - stroke | Hospitalized patients with stroke Receives: Diagnostic Test: Respiratory virus testing | |
| Hospitalized - chronic lung disease | Hospitalized patients with exacerbation of chronic lung disease Receives: Diagnostic Test: Respiratory virus testing | |
| Outpatient | Outpatients Receives: Diagnostic Test: Respiratory virus testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory viruses
Incidence of respiratory viruses
Measured: 2 days
Secondary outcomes (18)
Length of hospital stay
Length of hospital stay
Measured: 1 month
Length of stay in general medical ward
Length of stay in general medical ward
Measured: 1 month
Length of stay in high dependency unit
Length of stay in high dependency unit
Measured: 1 month
Length of stay in intensive care unit
Length of stay in intensive care unit
Measured: 1 month
Proportion of patients requiring oxygen supplementation
Proportion of patients requiring oxygen supplementation
Measured: 1 month
Proportion of patients requiring positive pressure ventilation
Proportion of patients requiring positive pressure ventilation
Measured: 1 month
Proportion of patients requiring intubation
Proportion of patients requiring intubation
Measured: 1 month
Proportion of patients admitted to intensive care unit
Proportion of patients admitted to intensive care unit
Measured: 1 month
Proportion of patients admitted to coronary care unit
Proportion of patients admitted to coronary care unit
Measured: 1 month
Proportion of patients admitted to high dependency unit
Proportion of patients admitted to high dependency unit
Measured: 1 month
Proportion of patients who die during hospitalization
Proportion of patients who die during hospitalization
Measured: 1 month
White blood cell on admission
White blood cell count in blood (x 10^9 cells/L)
Measured: 1 day
Platelet count upon admission
Platelet count in blood (x 10^9 cells/L) upon admission
Measured: 1 day
Alanine aminotransferase upon admission
The level of alanine aminotransferase in blood (U/L)
Measured: 1 day
Creatinine on admission
The level of creatinine in blood (umol/L) upon
Measured: 1 day
Blood culture result
The result of blood culture
Measured: 3 days
Sputum culture result
The result of sputum culture
Measured: 3 days
Proportion of patients with pneumonia
Proportion of patients with pneumonia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start12 Feb 2019
- Primary completion30 Jun 2019
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Virus InfectionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816059
- Sponsor's protocol ID
- 20190104
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28745014To 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.
PubMed 26921740Warren-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.
PubMed 29563170To 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.
PubMed 28588283To 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.
PubMed 29906597
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications
- ClinicalTrials.gov ID
- NCT03816059
- Acronym / sponsor ID
- 20190104
- Keywords
- Respiratory virus infection, Extrapulmonary complications, Myocardial infarction, Asthma, Bronchiectasis, Chronic obstructive pulmonary disease, Cerebrovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hospitalized - ACS | – | Diagnostic Test: Respiratory virus testingHospitalized patients with acute coronary syndrome |
| Hospitalized - stroke | – | Diagnostic Test: Respiratory virus testingHospitalized patients with stroke |
| Hospitalized - chronic lung disease | – | Diagnostic Test: Respiratory virus testingHospitalized patients with exacerbation of chronic lung disease |
| Outpatient | – | Diagnostic Test: Respiratory virus testingOutpatients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Hospitalized patients with acute coronary syndrome, stroke or exacerbation of underlying lung disease 2. Outpatients follow-up for chronic conditions
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Admitted to any hospitals in the past 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory virus testingAll patients will be tested for respiratory viruses | Diagnostic test | Hospitalized - ACS, Hospitalized - chronic lung disease, Hospitalized - stroke, Outpatient |
Primary outcome
Incidence of respiratory viruses
Time frame: 2 days
Incidence of respiratory viruses
18 secondary outcomes
Length of hospital stay
Time frame: 1 month
Length of stay in general medical ward
Time frame: 1 month
Length of stay in high dependency unit
Time frame: 1 month
Length of stay in intensive care unit
Time frame: 1 month
Proportion of patients requiring oxygen supplementation
Time frame: 1 month
Proportion of patients requiring positive pressure ventilation
Time frame: 1 month
Proportion of patients requiring intubation
Time frame: 1 month
Proportion of patients admitted to intensive care unit
Time frame: 1 month
Proportion of patients admitted to coronary care unit
Time frame: 1 month
Proportion of patients admitted to high dependency unit
Time frame: 1 month
Proportion of patients who die during hospitalization
Time frame: 1 month
White blood cell on admission
Time frame: 1 day
Platelet count upon admission
Time frame: 1 day
Alanine aminotransferase upon admission
Time frame: 1 day
Creatinine on admission
Time frame: 1 day
Blood culture result
Time frame: 3 days
Sputum culture result
Time frame: 3 days
Proportion of patients with pneumonia
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Results publication: PubMed 28745014Sellers 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.
- Results publication: PubMed 26921740To 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.
- Results publication: PubMed 29563170Warren-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.
- Results publication: PubMed 28588283To 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.
- Results publication: PubMed 29906597To 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Virus Infection and Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelvin To, MD ((852)-22552413, kelvinto@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory viruses (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816059, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.