Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, 13100, France
Location status: Recruiting
NCT Number: NCT06607055
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aix-en-Provence, 13100, France
Location status: Recruiting
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 relapses/recurrences 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HLA-DR dosage, at the time of inclusion and once a week then
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
Number of occurrence of a VAP recurrence/relapse
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
To search for association between immunoplegia depth and viral reactivation (CMV)
Time frame: First 24 hours
To search for association between immunoplegia depth and severity of the initial state of shock (lactatemia, amine dosage, SOFA score over 48 hours)
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
To compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
To compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Intercommunal Aix-Pertuis
Other
Monitoring of Immunity Markers in Intensive Care Patients and Link with Recurrence and Relapse of Ventilator-associated Pneumonia
Acronym: IMMUNAIX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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