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

Diasorin Italia S.p.A.

Status: Completed

Conditions: Pneumonia

Treatments: Diagnostic Test: PTX3 assay

Study type: Observational

Funder types: Industry

Identifiers

NCT06491004

CLI-PR-2104

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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