Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia

NCT04652167 | Completed

• 1 other identifier: SHS-ED-11d-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 C-reactive protein (CRP), serum procalcitonin (PCT) and soluble urokinase plasminogen activator receptor (suPAR) in the initial investigation of patients acute hospitalized with suspected community-acquired-pneumonia (CAP)

Conditions

Pneumonia, Bacterial

Keywords

C-reactive protein,; serum procalcitonin,; soluble urokinase plasminogen activator receptor

Outcome Measures

Primary Outcomes (1)

• Diagnostic of community acquired pneumonia

  The percentage of patients diagnosed with community-acquired pneumonia determined by an expert panel. This outcome measure is a binary variable - verified pneumonia or no pneumonia. The expert panel consists of two independent consultants from the emergency department with experience in infection and emergency medicine, who individually will determine whether the patient admitted with suspected community-acquired pneumonia, had the diagnosis. The diagnosis will be based on all available relevant information from the patient medical record within 48 hours from admission including computed tomography. A standardized template will be used. Disagreement will be discussed until a consensus is reached. .

  expert assessment within 3 months after patient discharge from the hospital

Secondary Outcomes (6)

• Intensive care unit (ICU) treatment

  within 60 days from admission to the emergency department

• Length of hospital stay (LOS

  within 60 days from current admission to the emergency department

• 30-days mortality

  30 days from the admission to the emergency department

• 90-days mortality

  90 days from the admission to the emergency department

• Readmission

  within 30 days from the discharge to the hospital

Other Outcomes (4)

• CURB-65 score for predicting mortality in community-acquired-pneumonia:

  within 4 hours from admission

• Pneumonia severity index (PSI):

  within 4 hours from admission

• Microbial agents

  results within 7 days from sputum sample collection

Study Arms (1)

Patients suspected of community-acquired pneumonia

All patients admitted to the emergency department with suspected community- acquired pneumonia by the attending physician

Diagnostic Test: PCT; Diagnostic Test: suPAR; Diagnostic Test: Standard care

Interventions

PCT DIAGNOSTIC_TEST

Serum PCT concentration is quantified with an automated sandwich immunoassay "ECLIA" (Elecsys®, BRAHMS PCT-analyses) on Cobas e801. Calibration (BRAHMS PCT LIA assay) is performed once per reagent lot and no later than 24 h after Cobas e pack has been registered in the instrument. Quality control is performed after each calibration.

Patients suspected of community-acquired pneumonia

suPAR DIAGNOSTIC_TEST

Serum suPAR was measured using suPARnostic© Turbilatex assay reagents (validated on Cobas© c111) protocol for Cobas© c702 and c502 applying the Multi-Pack cassettes (Roche Diagnostics, Mannheim, Germany). Calibration is performed at least once a month or in connection to a new batch of TurbiLatex reagents, after calibration a quality control is performed.

Patients suspected of community-acquired pneumonia

Standard care DIAGNOSTIC_TEST

Standard care is the measurement of CRP (C-reactive protein) will be measured with C - reactive protein (CRP4) immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi cobas© systems c701/702. Calibration is performed (Tina-quant® C - reactive protein IV) once per reagent lot and after 6 months using the same reagent lot. Quality control is required after calibration and according manufacturing instructions.

Patients suspected of community-acquired pneumonia

Eligibility Criteria

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

Study Population

Patients admitted at the emergency department with suspected pneumonia by the attending physician.

You may qualify if:

• Adult patients ≥ 18 years old
• Patients suspected with pneumonia by the attending physician. The physician will base his/her suspicion on e.g. clinical symptoms such as cough, increased sputum production, chest tightness, dyspnea and fever \> 38⁰C, and indication for chest x-ray

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 (8)

• Johnstone J, Mandell L. Guidelines and quality measures: do they improve outcomes of patients with community-acquired pneumonia? Infect Dis Clin North Am. 2013 Mar;27(1):71-86. doi: 10.1016/j.idc.2012.11.001.

  PMID: 23398866 BACKGROUND

• Musher DM, Thorner AR. Community-acquired pneumonia. N Engl J Med. 2014 Oct 23;371(17):1619-28. doi: 10.1056/NEJMra1312885. No abstract available.

  PMID: 25337751 BACKGROUND

• Hey J, Thompson-Leduc P, Kirson NY, Zimmer L, Wilkins D, Rice B, Iankova I, Krause A, Schonfeld SA, DeBrase CR, Bozzette S, Schuetz P. Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis. Clin Chem Lab Med. 2018 Jul 26;56(8):1200-1209. doi: 10.1515/cclm-2018-0126.

  PMID: 29715176 BACKGROUND

• Wussler D, Kozhuharov N, Tavares Oliveira M, Bossa A, Sabti Z, Nowak A, Murray K, du Fay de Lavallaz J, Badertscher P, Twerenbold R, Shrestha S, Flores D, Nestelberger T, Walter J, Boeddinghaus J, Zimmermann T, Koechlin L, von Eckardstein A, Breidthardt T, Mueller C. Clinical Utility of Procalcitonin in the Diagnosis of Pneumonia. Clin Chem. 2019 Dec;65(12):1532-1542. doi: 10.1373/clinchem.2019.306787. Epub 2019 Oct 15.

  PMID: 31615771 BACKGROUND

• Loonen AJM, Kesarsing C, Kusters R, Hilbink M, Wever PC, van den Brule AJC. High pneumococcal DNA load, procalcitonin and suPAR levels correlate to severe disease development in patients with pneumococcal pneumonia. Eur J Clin Microbiol Infect Dis. 2017 Sep;36(9):1541-1547. doi: 10.1007/s10096-017-2963-2. Epub 2017 Mar 29.

  PMID: 28353184 BACKGROUND

• Ni W, Han Y, Zhao J, Cui J, Wang K, Wang R, Liu Y. Serum soluble urokinase-type plasminogen activator receptor as a biological marker of bacterial infection in adults: a systematic review and meta-analysis. Sci Rep. 2016 Dec 19;6:39481. doi: 10.1038/srep39481.

  PMID: 27991579 BACKGROUND

• Song S, Jia Q, Chen X, Lei Z, He X, Leng Z, Chen S. Serum suPAR associated with disease severity and mortality in elderly patients with community-acquired pneumonia. Scand J Clin Lab Invest. 2020 Oct;80(6):515-522. doi: 10.1080/00365513.2020.1795920. Epub 2020 Jul 27.

  PMID: 32716662 BACKGROUND

• Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606.

  PMID: 34593497 DERIVED

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

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: November 26, 2020
• First Posted: December 3, 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)