Accuracy of Lung Injury Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia

NCT04686331 | Completed

• 1 other identifier: SHS-ED-12d-2020
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Keywords

surfactant protein D; Krebs von den Lungen; YKL-40 C; pneumonia; lung injury; diagnostic markers; prognostic markers; emergency department

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months after patient discharge

Secondary Outcomes (6)

• Intensive care unit treatment

  within 60 days from admission to the emergency department

• Length of stay

  within 60 days from current admission to the emergency department

• the number of participants who died within 30 days

  within 30 days from arrival day

• The number of participants who died within 90 days

  within 90 days from arrival day

• Readmission

  within 30 days from day of discharge

Other Outcomes (8)

• Bacteriuria

  urine collected within 4 hours of arrival to emergency department

• Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia

  Within 24 hours from hospital admission

• Diagnostic capabilities of lung ultrasound for pneumonia

  Within 24 hours from hospital admission

Study Arms (1)

Suspected CAP

All patients admitted to the emergency department with suspected community-acquired pneumonia (CAP) assessed by the receiving physician

Diagnostic Test: Biomarkers for pneumonia

Interventions

Biomarkers for pneumonia DIAGNOSTIC_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

Suspected CAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Suspicion of APN assessed by the receiving physician at the ED

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (3)

• 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.

  PMID: 22554854 BACKGROUND

• 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.

  PMID: 29473039 BACKGROUND

• 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.

  PMID: 20347285 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia; Lung Injury; Emergencies

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Backer Mogensen

  University Hospital of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)