Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491004
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-06
Brief Title:
Evaluation of DiaSorin LIAISON PTX3 Long Pentraxin 3 Assay in Patients With Pneumonia
Sponsor:
Diasorin Italia SpA
Organization:
Diasorin Italia SpA
Study Overview
Official Title:
Evaluation of DiaSorin LIAISON PTX3 Long Pentraxin 3 Assay in Patients With Pneumonia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None