Immunity Markers in Intensive Care Patients and Ventilator-associated Pneumonia (IMMUNAIX)

September 18, 2024 updated by: Laurent LEFEBVRE, Centre Hospitalier Intercommunal Aix-Pertuis

Monitoring of Immunity Markers in Intensive Care Patients and Link with Recurrence and Relapse of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Aix-en-Provence, France, 13100
        • Recruiting
        • Centre Hospitalier Intercommunal Aix-Pertuis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient admitted in the ICU of the CHIAP under mechanical ventilation and with infectious pneumonia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interventional - blood collection
HLA-DR dosage, at the time of inclusion and once a week then
Diagnostic test: Blood collection
HLA-DR dosage, at the time of inclusion and once a week then

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
First 24 hours
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Aix-Pertuis

Investigators

  • Principal Investigator: Laurent LEFEBVRE, MD, Centre Hospitalier Intercommunal Aix-Pertuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20232704-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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