Clinical trial NCT04686331: Accuracy of Lung Injury Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-acquired Pneumonia
Keywords: surfactant protein D
Krebs von den Lungen
YKL-40 C
pneumonia
lung injury
diagnostic markers
prognostic markers
emergency department
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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. 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

Eligibility criteria: 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)

Primary outcomes:
measure: Verified and non-verified community acquired pneumonia (CAP)
timeFrame: 2 months after patient discharge
Secondary outcomes:
measure: Intensive care unit treatment
timeFrame: within 60 days from admission to the emergency department
measure: Length of stay
timeFrame: within 60 days from current admission to the emergency department
measure: the number of participants who died within 30 days
timeFrame: within 30 days from arrival day
measure: The number of participants who died within 90 days
timeFrame: within 90 days from arrival day
measure: Readmission
timeFrame: within 30 days from day of discharge
measure: In-hospital mortality
timeFrame: within 60 days from admission to the emergency department
Other outcomes:
measure: Bacteriuria
timeFrame: urine collected within 4 hours of arrival to emergency department
measure: Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia
timeFrame: Within 24 hours from hospital admission
measure: Diagnostic capabilities of lung ultrasound for pneumonia
timeFrame: Within 24 hours from hospital admission
measure: Diagnostic capabilities of chest x-ray for pneumonia
timeFrame: Within 24 hours from hospital admission
measure: Level of infection markers
timeFrame: blood collected with 4 hours of arrival to emergency department
measure: CURB-65 severity score
timeFrame: within 4 hours from admission
measure: Pneumonia severity index (PSI)
timeFrame: within 4 hours from admission
measure: Microbial agents
timeFrame: results within 7 days from sputum sample collection
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
Study officials:
affiliation: University Hospital of Southern Denmark
name: Christian Backer Mogensen
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.