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Completed

NCT Number: NCT04686331

Accuracy of Lung Injury Biomarkers 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Southern Jutland

Aabenraa, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intensive care unit treatment

    Time frame: within 60 days from admission to the emergency department

    transfer to ICU during current admission (binary outcome)

  2. Length of stay

    Time frame: within 60 days from current admission to the emergency department

    days spent in hospital during current admission

  3. the number of participants who died within 30 days

    Time frame: within 30 days from arrival day

    binary - 30-days mortality

  4. The number of participants who died within 90 days

    Time frame: within 90 days from arrival day

    binary - 90-days mortality

  5. Readmission

    Time frame: within 30 days from day of discharge

    binary

  6. In-hospital mortality

    Time frame: within 60 days from admission to the emergency department

    binary

Other outcomes

  1. Bacteriuria

    Time frame: urine collected within 4 hours of arrival to emergency department

    Binary outcome defined by microbiologist on urine culture analysis

  2. Diagnostic capabilities of Ultra low-dose computer thermography for pneumonia

    Time frame: Within 24 hours from hospital admission

    True positive, true negative, false positive and false negative for ultra low-dose computer thermography for pneumonia.

  3. Diagnostic capabilities of lung ultrasound for pneumonia

    Time frame: Within 24 hours from hospital admission

    True positive, true negative, false positive and false negative for lunge ultrasound for pneumonia.

  4. Diagnostic capabilities of chest x-ray for pneumonia

    Time frame: Within 24 hours from hospital admission

    True positive, true negative, false positive and false negative for chest x-ray for pneumonia

  5. Level of infection markers

    Time frame: blood collected with 4 hours of arrival to emergency department

    Concentration of serum procalcitonin, CRP and suPAR

  6. CURB-65 severity score

    Time frame: within 4 hours from admission

    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).

  7. Pneumonia severity index (PSI)

    Time frame: within 4 hours from admission

    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)

  8. Microbial agents

    Time frame: results within 7 days from sputum sample collection

    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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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