Community-acquired PneumoniaNCT04686331
Accuracy of Lung Injury Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia
An observational study of Community-acquired Pneumonia, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the diagnostic and prognostic value of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the initial investigation of patients hospitalized with suspected pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Biomarkers for pneumonia
- How many people
- 411 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Jun 2022
- 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: Acutely admitted patients with suspected Acute pyelonephritis (APN) from three emergency departments (EDs) in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)
Who may be able to join
- Suspicion of APN assessed by the receiving physician at the ED
Who cannot join
- If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
- Admission within the last 14 days
- Verified COVID-19 disease within 14 days before admission
- Pregnant women
- Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Prognostic Accuracy of Surfactant Protein D, Krebs Von Den Lungen, and Chitinase-3-like Protein 1 (YKL-40 ) in the Initial Investigation of Patients With Suspected Pneumonia
The aim of this study is to investigate the diagnostic and prognostic value of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the initial investigation of patients hospitalized with suspected pneumonia. This to improve the diagnosis of pneumonia, contribute to a more rapid and accurate antibiotic treatment, and assess disease severity to predict short-term and long-term mortality in community-acquired pneumonia patients.
Read the detailed description
Community-acquired pneumonia (CAP) is one of the most common infection diseases in the emergency department (ED). Diagnosis of pneumonia is challenging as symptoms are often weak and nonspecific and the current methods for focal and etiological diagnosis have low sensitivity and specificity and often deliver results after the antibiotic treatment decision has been made.
The abundant and restricted expression of surfactant protein D (SP-D) within the lung makes this protein a specific marker for lung disease. Krebs von den Lungen-6 (KL-6) is expressed in the lung and is a diagnostic and prognostic marker of interstitial lung disease. The inflammatory glycoprotein Chitinase-3-like protein 1 commonly known as YKL-40 is associated with severity of interstitial lung disease. The value of these lung injury markers for diagnosing pneumonia needs further investigation.
The investigators hypothesize that surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) have an impact on diagnosing, prognosis, and treatment of patients with verified CAP.
The objectives of the study are:
- To investigate the diagnostic accuracy of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the diagnosis of CAP
- To identify the prognostic value surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in relation to adverse events in patients with verified CAP
- Conditions
- Community-acquired Pneumonia
- Being tested
- Biomarkers for pneumonia
- Keywords
- surfactant protein D, Krebs von den Lungen, YKL-40 C, pneumonia, lung injury, diagnostic markers, prognostic markers, emergency department
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Lung Injury, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers for pneumoniaDiagnostic test
Blood samples will be collected by a medical laboratory technologist and transferred to the local laboratory for analysis of surfactant protein D, Krebs von den Lungen (KL-6), and YKL-40. Laboratory staff will be blinded to participant diagnosis and outcome. None of the biomarkers will be available to the treating physician.
- Diagnostic test of surfactant protein D - will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis
- Diagnostic test of KL-6: will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis
- Diagnostic test of YKL-40 - will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis
| Study group | Role | What they receive |
|---|---|---|
| Suspected CAP | All patients admitted to the emergency department with suspected community-acquired pneumonia (CAP) assessed by the receiving physician Receives: Diagnostic Test: Biomarkers for pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verified and non-verified community acquired pneumonia (CAP)
The decision of whether patients admitted with suspicion of CAP actually has a final diagnosis of CAP is based on a combination of all findings during admission. The verification of diagnosis requires human handling, interpretation and judgment. Therefore, in this study, an expert panel will define the reference standard for the diagnosis CAP. The expert panel consists of two independent consultants from the emergency department with significant experience in emergency medicine and acute infections. They will individually determine whether or not the patient admitted suspected with CAP actually had this diagnosis. The final diagnosis will be based on all available relevant information from the patient medical record including HR-CT of lungs. A standardized template will be used. Disagreement will be discussed until a consensus is reached.
Measured: 2 months after patient discharge
Secondary outcomes (6)
Intensive care unit treatment
transfer to ICU during current admission (binary outcome)
Measured: within 60 days from admission to the emergency department
Length of stay
days spent in hospital during current admission
Measured: within 60 days from current admission to the emergency department
the number of participants who died within 30 days
binary - 30-days mortality
Measured: within 30 days from arrival day
The number of participants who died within 90 days
binary - 90-days mortality
Measured: within 90 days from arrival day
Readmission
binary
Measured: within 30 days from day of discharge
In-hospital mortality
binary
Measured: within 60 days from admission to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Mar 2021
- Primary completion28 Feb 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Backer Mogensen, Study chair, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686331
- Sponsor's protocol ID
- SHS-ED-12d-2020
- Status last verified
- Sep 2022
- First submitted
- 22 Dec 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ishikawa N, Hattori N, Yokoyama A, Kohno N. Utility of KL-6/MUC1 in the clinical management of interstitial lung diseases. Respir Investig. 2012 Mar;50(1):3-13. doi: 10.1016/j.resinv.2012.02.001. Epub 2012 Mar 8.
PubMed 22554854Sorensen GL. Surfactant Protein D in Respiratory and Non-Respiratory Diseases. Front Med (Lausanne). 2018 Feb 8;5:18. doi: 10.3389/fmed.2018.00018. eCollection 2018.
PubMed 29473039Furuhashi K, Suda T, Nakamura Y, Inui N, Hashimoto D, Miwa S, Hayakawa H, Kusagaya H, Nakano Y, Nakamura H, Chida K. Increased expression of YKL-40, a chitinase-like protein, in serum and lung of patients with idiopathic pulmonary fibrosis. Respir Med. 2010 Aug;104(8):1204-10. doi: 10.1016/j.rmed.2010.02.026. Epub 2010 Mar 27.
PubMed 20347285
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Accuracy of Surfactant Protein D, Krebs Von Den Lungen, and Chitinase-3-like Protein 1 (YKL-40 ) in the Initial Investigation of Patients With Suspected Pneumonia
- ClinicalTrials.gov ID
- NCT04686331
- Acronym / sponsor ID
- SHS-ED-12d-2020
- Conditions
- Community-acquired Pneumonia
- Keywords
- surfactant protein D, Krebs von den Lungen, YKL-40 C, pneumonia, lung injury, diagnostic markers, prognostic markers, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Dec 2020 (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.
The aim of this study is to investigate the diagnostic and prognostic value of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the initial investigation of patients hospitalized with suspected pneumonia. This to improve the diagnosis of pneumonia, contribute to a more rapid and accurate antibiotic treatment, and assess disease severity to predict short-term and long-term mortality in community-acquired pneumonia patients.
Detailed description
Community-acquired pneumonia (CAP) is one of the most common infection diseases in the emergency department (ED). Diagnosis of pneumonia is challenging as symptoms are often weak and nonspecific and the current methods for focal and etiological diagnosis have low sensitivity and specificity and often deliver results after the antibiotic treatment decision has been made.
The abundant and restricted expression of surfactant protein D (SP-D) within the lung makes this protein a specific marker for lung disease. Krebs von den Lungen-6 (KL-6) is expressed in the lung and is a diagnostic and prognostic marker of interstitial lung disease. The inflammatory glycoprotein Chitinase-3-like protein 1 commonly known as YKL-40 is associated with severity of interstitial lung disease. The value of these lung injury markers for diagnosing pneumonia needs further investigation.
The investigators hypothesize that surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) have an impact on diagnosing, prognosis, and treatment of patients with verified CAP.
The objectives of the study are:
- To investigate the diagnostic accuracy of surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in the diagnosis of CAP
- To identify the prognostic value surfactant protein D, Krebs von den Lungen (KL-6), and Chitinase-3-like protein 1 (YKL-40) in relation to adverse events in patients with verified CAP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected CAP | – | Diagnostic Test: Biomarkers for pneumoniaAll patients admitted to the emergency department with suspected community-acquired pneumonia (CAP) assessed by the receiving physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely admitted patients with suspected Acute pyelonephritis (APN) from three emergency departments (EDs) in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)
Key inclusion criteria (1 listed)
- Suspicion of APN assessed by the receiving physician at the ED
Key exclusion criteria (5 listed)
- If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
- Admission within the last 14 days
- Verified COVID-19 disease within 14 days before admission
- Pregnant women
- Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 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 |
|---|---|---|
| Biomarkers for pneumoniaBlood samples will be collected by a medical laboratory technologist and transferred to the local laboratory for analysis of surfactant protein D, Krebs von den Lungen (KL-6), and YKL-40. Laboratory staff will be blinded to participant diagnosis and outcome. None of the biomarkers will be available to the treating physician. * Diagnostic test of surfactant protein D - will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis * Diagnostic test of KL-6: will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis * Diagnostic test of YKL-40 - will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis | Diagnostic test | Suspected CAP |
Primary outcome
Verified and non-verified community acquired pneumonia (CAP)
Time frame: 2 months after patient discharge
The decision of whether patients admitted with suspicion of CAP actually has a final diagnosis of CAP is based on a combination of all findings during admission. The verification of diagnosis requires human handling, interpretation and judgment. Therefore, in this study, an expert panel will define the reference standard for the diagnosis CAP. The expert panel consists of two independent consultants from the emergency department with significant experience in emergency medicine and acute infections. They will individually determine whether or not the patient admitted suspected with CAP actually had this diagnosis. The final diagnosis will be based on all available relevant information from the patient medical record including HR-CT of lungs. A standardized template will be used. Disagreement will be discussed until a consensus is reached.
6 secondary outcomes
Intensive care unit treatment
Time frame: within 60 days from admission to the emergency department
Length of stay
Time frame: within 60 days from current admission to the emergency department
the number of participants who died within 30 days
Time frame: within 30 days from arrival day
The number of participants who died within 90 days
Time frame: within 90 days from arrival day
Readmission
Time frame: within 30 days from day of discharge
In-hospital mortality
Time frame: within 60 days from admission to the emergency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 22554854Ishikawa N, Hattori N, Yokoyama A, Kohno N. Utility of KL-6/MUC1 in the clinical management of interstitial lung diseases. Respir Investig. 2012 Mar;50(1):3-13. doi: 10.1016/j.resinv.2012.02.001. Epub 2012 Mar 8.
- Background: PubMed 29473039Sorensen GL. Surfactant Protein D in Respiratory and Non-Respiratory Diseases. Front Med (Lausanne). 2018 Feb 8;5:18. doi: 10.3389/fmed.2018.00018. eCollection 2018.
- Background: PubMed 20347285Furuhashi K, Suda T, Nakamura Y, Inui N, Hashimoto D, Miwa S, Hayakawa H, Kusagaya H, Nakano Y, Nakamura H, Chida K. Increased expression of YKL-40, a chitinase-like protein, in serum and lung of patients with idiopathic pulmonary fibrosis. Respir Med. 2010 Aug;104(8):1204-10. doi: 10.1016/j.rmed.2010.02.026. Epub 2010 Mar 27.
- 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.
Christian Backer Mogensen study chair
Esbjerg Hospital - University Hospital of Southern Denmark
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 Community-acquired Pneumonia, run by University of Southern Denmark at 1 site in Denmark.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 14 Sep 2022. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verified and non-verified community acquired pneumonia (CAP) (time frame: 2 months after patient discharge). 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 NCT04686331, which also lists 3 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 14 Sep 2022.