- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686331
Accuracy of Lung Injury Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aabenraa, Denmark
- Hospital of Southern Jutland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspicion of APN assessed by the receiving physician at the ED
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Suspected CAP
All patients admitted to the emergency department with suspected community-acquired pneumonia (CAP) assessed by the receiving physician
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verified and non-verified community acquired pneumonia (CAP)
Time Frame: 2 months after patient discharge
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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.
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2 months after patient discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission
Time Frame: within 30 days from day of discharge
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binary
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within 30 days from day of discharge
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Intensive care unit treatment
Time Frame: within 60 days from admission to the emergency department
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transfer to ICU during current admission (binary outcome)
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within 60 days from admission to the emergency department
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Length of stay
Time Frame: within 60 days from current admission to the emergency department
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days spent in hospital during current admission
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within 60 days from current admission to the emergency department
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the number of participants who died within 30 days
Time Frame: within 30 days from arrival day
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binary - 30-days mortality
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within 30 days from arrival day
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The number of participants who died within 90 days
Time Frame: within 90 days from arrival day
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binary - 90-days mortality
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within 90 days from arrival day
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In-hospital mortality
Time Frame: within 60 days from admission to the emergency department
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binary
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within 60 days from admission to the emergency department
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacteriuria
Time Frame: urine collected within 4 hours of arrival to emergency department
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Binary outcome defined by microbiologist on urine culture analysis
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urine collected within 4 hours of arrival to emergency department
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Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia
Time Frame: Within 24 hours from hospital admission
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True positive, true negative, false positive and false negative for ultra low-dose computer thermography for pneumonia.
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Within 24 hours from hospital admission
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Diagnostic capabilities of lung ultrasound for pneumonia
Time Frame: Within 24 hours from hospital admission
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True positive, true negative, false positive and false negative for lunge ultrasound for pneumonia.
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Within 24 hours from hospital admission
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Diagnostic capabilities of chest x-ray for pneumonia
Time Frame: Within 24 hours from hospital admission
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True positive, true negative, false positive and false negative for chest x-ray for pneumonia
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Within 24 hours from hospital admission
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Level of infection markers
Time Frame: blood collected with 4 hours of arrival to emergency department
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Concentration of serum procalcitonin, CRP and suPAR
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blood collected with 4 hours of arrival to emergency department
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CURB-65 severity score
Time Frame: within 4 hours from admission
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Confusion of new onset, Blood Urea nitrogen greater than 7 mmol/L (19 mg/dL), respiratory rate of 30 breaths per minute or greater, blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less and age 65 or older.
The score stratify patients to groups 1 (mild pneumonia), 2 (moderate pneumonia) and 3-5 (severe pneumonia).
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within 4 hours from admission
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Pneumonia severity index (PSI)
Time Frame: within 4 hours from admission
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Risk classes to predict the severity of pneumonia.
Scores are given based on demographics, comorbidity, clinical measurements and physical Exam Findings (<70 = Risk Class II, 71-90 = Risk Class III, 91-130 = Risk Class IV, >130 = Risk Class V)
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within 4 hours from admission
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Microbial agents
Time Frame: results within 7 days from sputum sample collection
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Microbial agents (bacteria and viruses) identified in standard culture, PCR and multiplex PCR.
Sputum or tracheal secretion samples are collected within 1 hour from patient admission.
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results within 7 days from sputum sample collection
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Christian Backer Mogensen, University Hospital of Southern Denmark
Publications and helpful links
General Publications
- Sorensen 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.
- 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.
- Furuhashi 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHS-ED-12d-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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