Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607055
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Immunity Markers in Intensive Care Patients and Ventilator-associated Pneumonia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Monitoring of Immunity Markers in Intensive Care Patients and Link with Recurrence and Relapse of Ventilator-associated Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMMUNAIX
Brief Summary:
The goal of this observational study is to show the direct correlation between the occurrence of recurrence of VAP and postagressive immunoparalysis monitored by HLA-DR rate below litterature-acknowledged threshold in a well conducted antibiotherapy context in patient admitted in the Intensive Care Unit
The main questions it aims to answer are
evaluation of the association between death and persistence of immunoplegia using HLA-DR monitoring
search an association between immunoplegia depth and severity of the initial state of shock
search an association between immunoplegia depth and viral reactivation
compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence Blood samples will be taken from participants to HLA-DR dosage at the time of inclusion and once a week then
The main questions it aims to answer are
evaluation of the association between death and persistence of immunoplegia using HLA-DR monitoring
search an association between immunoplegia depth and severity of the initial state of shock
search an association between immunoplegia depth and viral reactivation
compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence Blood samples will be taken from participants to HLA-DR dosage at the time of inclusion and once a week then
Detailed Description:
The occurrence of ICU-acquired infections in patients admitted to the intensive care unit ICU results in increased morbidity and mortality increased length of stay in the ICU and also clearly increased healthcare costs The incidence of these infections fluctuates between 15 and 40 depending on the study A major problem in the ICU is the recurrence and relapse of ventilator-associated pneumonia VAP with increased exposure to antibiotics and a probable increase in average length of stay
One of the possible hypothesis that could explain relapsesrecurrences of VAP is incorrect conducted antibiotherapy To prevent this in the unit we currently perform antibiotics pharmacological assays and adapt them to the antibiogram Another possible explanation to treatment failure could be patients postagressive immunoparalysis It has clearly been demonstrated that postagressive immunoparalysis is a predisposing state to healthcare related infections
Some markers can be used to monitor this immunoplegia state Several studies have shown that low HLA-DR expression and reduced CD16 expression polymorphonuclear neutrophils percentage is associated with increased susceptibility to develop infections in the ICU
Immunity monitoring could be an interesting tool to identify populations most at risk of developing healthcare-associated infections after a state of shock and could become an interesting line of thinking for the use of immunomodulatory therapies To best evaluate these therapies and find a place for them in the current arsenal it is essential to integrate them into daily practice by linking them to a significant clinical event such as recurrent healthcare-associated infections despite properly conducted antibiotic treatment
One of the possible hypothesis that could explain relapsesrecurrences of VAP is incorrect conducted antibiotherapy To prevent this in the unit we currently perform antibiotics pharmacological assays and adapt them to the antibiogram Another possible explanation to treatment failure could be patients postagressive immunoparalysis It has clearly been demonstrated that postagressive immunoparalysis is a predisposing state to healthcare related infections
Some markers can be used to monitor this immunoplegia state Several studies have shown that low HLA-DR expression and reduced CD16 expression polymorphonuclear neutrophils percentage is associated with increased susceptibility to develop infections in the ICU
Immunity monitoring could be an interesting tool to identify populations most at risk of developing healthcare-associated infections after a state of shock and could become an interesting line of thinking for the use of immunomodulatory therapies To best evaluate these therapies and find a place for them in the current arsenal it is essential to integrate them into daily practice by linking them to a significant clinical event such as recurrent healthcare-associated infections despite properly conducted antibiotic treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None