Evaluation of DiaSorin LIAISON® PTX3 (Long Pentraxin 3) Assay in Patients With Pneumonia

LIAISON® PTX3 is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of Long Pentraxin 3 (PTX3) in human plasma samples.

LIAISON® PTX3, in conjunction with clinical evaluation and other laboratory findings, may serve as an aid in the determination of disease severity and prognosis of patients with community-acquired (CAP) and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas, Rozzano, Milan, Italy

About this study

Long Pentraxin 3 (PTX3) is an essential protein of innate immunity, produced by myeloid cells, endothelial cells and respiratory epithelial cells, and involved in resistance to selected pathogens and in inflammation. In different pathological conditions (infections of bacterial and viral origin, sepsis, and cardiovascular diseases) and in patients requiring admission to intensive care units (ICUs), PTX3 was detected in high concentrations in the circulation and was associated with disease severity and mortality.

PTX3 plasma concentration was found to be an independent prognostic indicator of short-term mortality (28 days) in hospitalized patients with Coronavirus Disease 2019 (COVID- 19) and higher PTX3 levels were found in ICU patients compared to ward patients. Moreover, PTX3 significantly correlated with the inflammatory molecules C-reactive protein (CRP), procalcitonin (PCT), and interleukin (IL)-6.

Given the association between PTX3 and inflammatory conditions, especially in the context of lung infections, the study aims to investigate the potential of PTX3 to be used as a severity marker and a prognostic predictor for outcome in patients with community-acquired (CAP) and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects willing and able to sign the approved Informed Consent form in accordance with international and national regulations
Patients diagnosed with pneumonia, either CAP, HAP, VAP
Collection of plasma samples within 24 hours from pneumonia diagnosis (for CAP diagnosis is usually made at ED presentation and for HAP and VAP diagnosis is made during hospital stay)
K2 EDTA plasma samples dedicated to the study have a minimum volume of 3 mL

Exclusion criteria

Patients who are currently pregnant
Samples collected and/or stored in an inappropriate way

Treatment and study plan

PTX3 assay

Diagnostic Test

PTX3 dosage by the in vitro medical device in evaluation.

Primary outcomes

Pneumonia severity measured by pneumonia specific index (PSI), CURB-65, and Sequential Organ Failure Assessment (SOFA) as a mortality prediction score

Time frame: Day 0 (baseline), day 3, day 7, at discarge, an average of 1 month (if applicable)

Evaluate Long Pentraxin 3 (PTX3) correlation with pneumonia severity and clinical outcome: pneumonia severity is assessed by clinical scores, specifically pneumonia severity index (PSI), CURB-65, Sequential Organ Failure Assessment (SOFA) and Horowitz Index as a mortality prediction score; clinical outcome means hospitalization, intensive care unit (ICU) admission, mortality (at 28 days), discharge.

PSI (pneumonia severity) score: I or II MILD; III MODERATE; IV or V SEVERE. CURB-65 score: 0-1 MILD; 2 MODERATE; 3-4-5 SEVERE SOFA score: 0 to 3 MILD; 4 to 9 MODERATE; 10 to 14 or more SEVERE

Clinical severity:

presence of unilateral pneumonia with less than 50% parenchymal involvement; basal bilateral pneumonia LOW unilateral pneumonia with more than 50% parenchymal involvement; bilateral with involvement of a large area of parenchyma HIGH

Horowitz Index (P/F ratio), mmHg:

>300 no distress respiratory syndrome; >200 to 300 MILD; >100 to 200 MODERATE; <=100 SEVERE
PTX3 cutoffs

Time frame: Day 0 (baseline), day 3, day 7, at discarge, an average of 1 month (if applicable)

Identify PTX3 cutoffs (LIAISON® PTX3 assay) to distinguish pneumonia severity: pneumonia severity is assessed by clinical scores (PSI, CURB-65, SOFA and Horowitz Indexas a mortality prediction score).

Details in Primary Outcome Measure 1

Sponsors and collaborators

Lead sponsor

Diasorin Italia S.p.A.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jul 8, 2024
Registry last updated: Jul 8, 2024

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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Completed