Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652167
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-11-26
Brief Title:
Diagnostic Accuracy of Infection Biomarkers in the Initial Investigation of Patients With Suspected Pneumonia
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
What is the Diagnostic and Prognostic Accuracy of C-reactive Protein Serum Procalcitonin and Soluble Urokinase Plasminogen Activator Receptor in the Initial Investigation of Patients With Suspected Community-acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2022-09
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:
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
Detailed Description:
Target pneumonia treatment should be initiated within a few hours which is why early and accurate diagnosis is extremely important Uncertain or delayed diagnosis will often lead to an overconsumption of broad-spectrum antibiotics which contributes to increased development of resistant bacteria and thus threaten the treatment options of the future Pneumonia diagnosis is primarily made today on the basis of clinical symptoms and findings in the form of cough vomiting chest pain fever shortness of breath supplemented with X-ray of the lungs relevant blood tests and analysis of expectoration However X-ray is an imprecise diagnostic tool The diagnosis of CAP is challenged by nonspecific symptoms uncertain diagnostic methods and waiting time for test results up to several days
Therefore numerous studies have investigated biomarkers that can possibly support the diagnosis of CAP C-reactive protein CRP and serum procalcitonin PCT are biomarkers that may distinguish CAP from other causes of acute respiratory infections The CRP biomarker has been endorsed as a guide for antibiotic treatment by the National Institute for Health and Care Excellence NICE and PCT was suggested by the American Infectious Diseases Society of America Soluble urokinase plasminogen activator receptor suPAR has emerged as a potentially novel biomarker for inflammatory diseases including pneumonia Several studies have highlighted suPAR as a significant prognostic mortality marker and strongly related to disease severity and worse outcome in a variety of conditions It is also a promising biological marker in the diagnosis of CAP
The diagnostic value of the optimal biomarkers for the diagnosis of CAP remains controversial The investigators hypothesize that serum CRP PTC and suPAR have an impact on diagnosing prognosis and treatment of patients with a verified community-acquired-pneumonia The objectives of the study are
To identify the diagnostic accuracy of CRP PCT and suPAR in community-acquired pneumonia
To identify the prognostic value of CRP PCT and suPAR in relation to adverse events
Therefore numerous studies have investigated biomarkers that can possibly support the diagnosis of CAP C-reactive protein CRP and serum procalcitonin PCT are biomarkers that may distinguish CAP from other causes of acute respiratory infections The CRP biomarker has been endorsed as a guide for antibiotic treatment by the National Institute for Health and Care Excellence NICE and PCT was suggested by the American Infectious Diseases Society of America Soluble urokinase plasminogen activator receptor suPAR has emerged as a potentially novel biomarker for inflammatory diseases including pneumonia Several studies have highlighted suPAR as a significant prognostic mortality marker and strongly related to disease severity and worse outcome in a variety of conditions It is also a promising biological marker in the diagnosis of CAP
The diagnostic value of the optimal biomarkers for the diagnosis of CAP remains controversial The investigators hypothesize that serum CRP PTC and suPAR have an impact on diagnosing prognosis and treatment of patients with a verified community-acquired-pneumonia The objectives of the study are
To identify the diagnostic accuracy of CRP PCT and suPAR in community-acquired pneumonia
To identify the prognostic value of CRP PCT and suPAR in relation to adverse events
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