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NCT Number: NCT06607055

Immunity Markers in Intensive Care Patients and Ventilator-associated Pneumonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, 13100, France

Location status: Recruiting

Location contact

Laurent LEFEBVRE

CONTACT

[email protected]

0442335650 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 18 years old
  • Patient admitted in the Intensive Care Unit of the CHIAP
  • Patient under mechanical ventilation
  • Patient with infectious pneumonia
  • Informed Consent Form (ICF) obtained from the patient or emergency ICF obtained from close relatives
  • Patient beneficiary of French social security, whatever the regime

Exclusion criteria

  • Patient under 18 years old
  • Patient with severe neutropenia (neutrophils < 0.5 G/L)
  • Patient under immunosuppressive treatment
  • Use of corticosteroids (intravenous or oral) prior to ICU admission
  • Use of therapeutic antibodies
  • Onco-hematological disease (e.g. lymphoma, leukemia...) under treatment or treated in the 5 years prior to inclusion
  • End of chemotherapy 6 months prior to inclusion
  • Patients with innate or acquired immune deficiency (e.g., severe combined immunodeficiency, HIV or AIDS, at any stage)
  • Patients with a decision to limit or discontinue active therapies, at the time of inclusion
  • Patients with an estimated ICU stay of less than 48 hours
  • Participation in an interventional study
  • Patient deprived of their liberty
  • Patient under tutorship or curatorship
  • Pregnant or breastfeeding woman

Treatment and study plan

Blood collection

Diagnostic Test

HLA-DR dosage, at the time of inclusion and once a week then

Primary outcomes

  1. 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

    Number of occurrence of a VAP recurrence/relapse

Secondary outcomes

  1. Viral reactivation

    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)

  2. Association between immunoparalysis depth and state of shock severity within the first 24 hours

    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)

  3. Persistence of immunoparalysis during hospitalization and care-related infections

    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

  4. HLA-DR nadir and link with care-related infections

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent LEFEBVRE, MD

CONTACT

[email protected]

0442335650 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Aix-Pertuis

Other

Registry information

Official study title

Monitoring of Immunity Markers in Intensive Care Patients and Link with Recurrence and Relapse of Ventilator-associated Pneumonia

Acronym: IMMUNAIX

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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