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

NCT06491004 | Completed

• 1 other identifier: CLI-PR-2104
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (2)

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

  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

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

• PTX3 cutoffs

  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

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

Interventions

PTX3 assay DIAGNOSTIC_TEST

PTX3 dosage by the in vitro medical device in evaluation.

Eligibility Criteria

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

Study Population

Patients with either CAP, HAP or VAP. Based on clinical evaluation and pneumonia severity assessment, patients will be hospitalized (in-patients) or not hospitalized (out-patients).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Diasorin Italia S.p.A.: lead

Study Sites (2)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Cliniche Humanitas Gavazzeni

Bergamo, 24125, Italy

Location

Related Publications (1)

• Voza A, Aliberti S, Bonelli F, Ingallinella P, Ghezzi E, Mauro C, Rossini C, Mastronardo C, Felotti S, Bottazzi B, Garlanda C, Zierold C, Ghignoni G, Mantovani A. A machine learning model including pentraxin-3 as predictor of outcomes in community-acquired pneumonia. J Transl Med. 2025 Oct 31;23(1):1205. doi: 10.1186/s12967-025-07142-6.

  PMID: 41174667 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

After collection, plasma and urine samples will be immediately processed, coded, and stored frozen at \<- 20 °C.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 8, 2024
• Study Start: September 20, 2021
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)