Immunity Markers in Intensive Care Patients and Ventilator-associated Pneumonia

NCT06607055 | Recruiting

• 1 other identifier: 20232704-9
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

• Occurrence of a VAP recurrence/relapse

  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 Outcomes (4)

• Viral reactivation

  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

  First 24 hours

• Persistence of immunoparalysis during hospitalization and care-related infections

  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

  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

Study Arms (1)

Interventional - blood collection

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

Diagnostic Test: Blood collection

Interventions

Blood collection DIAGNOSTIC_TEST

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

Interventional - blood collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with innate or acquired immune deficiency (e.g., severe combined immunodeficiency, HIV or AIDS, at any stage)
• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Aix-Pertuis: lead

Study Sites (1)

Centre Hospitalier Intercommunal Aix-Pertuis

Aix-en-Provence, 13100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

HLA-DR dosage

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurent LEFEBVRE, MD

  Centre Hospitalier Intercommunal Aix-Pertuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent LEFEBVRE, MD

CONTACT

0442335650; llefebvre@ch-aix.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 23, 2024
• Study Start: October 4, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)