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

NCT04652167 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2022-09-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

PCT

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.

DIAGNOSTIC_TEST

suPAR

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.

DIAGNOSTIC_TEST

Standard care

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.

Sponsors & Collaborators

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Christian Backer Mogensen · University Hospital of Southern Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-02-28
Completion
2022-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652167 on ClinicalTrials.gov