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NCT Number: NCT07551258

Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients

This prospective observational cohort study aims to evaluate the role of innate immune immunoparalysis in the development of ventilator-associated pneumonia (VAP) in critically ill mechanically ventilated patients. Immunoparalysis will be assessed through monocyte HLA-DR expression and ex vivo lipopolysaccharide (LPS)-stimulated TNF-α production.

The study will include three cohorts: elderly patients (≥65 years), younger adults (<65 years), and healthy controls. The primary objective is to determine whether the presence, duration, intensity, and trend of immunoparalysis are associated with the incidence of VAP and other ICU-acquired infections. Secondary objectives include characterization of immunoparalysis dynamics, comparison of measurement methods, and evaluation of clinical outcomes.

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Key information

Conditions

Intubated ICU Patients Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Immunoparalysis Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia ( VAP)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥18 years
  • Mechanical ventilation expected >48h
  • Intubation between 24h pre- and 48h post- ICU admission
  • Informed consent

Exclusion criteria

  • Known severe immunosuppression, including primary immunodeficiency disorders, advanced HIV infection (AIDS), active hematological malignancy under treatment, recent chemotherapy or immunosuppressive therapy
  • High dose steroids at immunosuppressive doses
  • Active autoimmune disease
  • Pregnancy
  • End-of-life situation

Treatment and study plan

Primary outcomes

  1. Incidence of ventilator-associated pneumonia (VAP)

    Time frame: Up to 28 days after intubation

    Occurrence of ventilator-associated pneumonia in critically ill mechanically ventilated patients, defined according to standard clinical, radiological, and microbiological criteria.

Secondary outcomes

  1. Incidence of ICU-acquired infections

    Time frame: Up to 28 days after intubation

    Occurrence of secondary infections acquired during ICU stay, including device-related infections and other nosocomial infections diagnosed according to standard clinical, microbiological, and radiological criteria.

  2. Duration of invasive mechanical ventilation

    Time frame: Up to 28 Days after intubation

    Total number of days under invasive mechanical ventilation during ICU stay.

  3. All-cause mortality at 28 days

    Time frame: 28 days after intubation

    Death from any cause within 28 days after ICU admission.

  4. Evolution of Sequential Organ Failure Assessment (SOFA) score

    Time frame: From ICU admission to day 15 or ICU discharge, whichever occurs first.

    Change in SOFA score over time during ICU stay as a measure of organ dysfunction trajectory.

  5. Prevalence of innate immune immunoparalysis at ICU admission

    Time frame: At ICU admission (baseline)

    Proportion of patients presenting innate immune immunoparalysis at ICU admission, defined by reduced monocyte HLA-DR expression (<5000 antibodies bound per cell [AB/C]) and/or decreased TNF-α production after ex vivo lipopolysaccharide (LPS) stimulation (<200 pg/mL), based on previously reported thresholds.

  6. Temporal evolution of innate immune immunoparalysis

    Time frame: Baseline, 24 hours, day 3, and day 5 after intubation

    Changes over time in innate immune immunoparalysis assessed by serial measurements of monocyte HLA-DR expression and ex vivo LPS-stimulated TNF-α production, including intensity, duration, and trends.

  7. Agreement between HLA-DR expression and LPS-stimulated TNF-α production

    Time frame: From baseline to day 5 after intubation.

    Concordance between monocyte HLA-DR expression and ex vivo LPS-stimulated TNF-α production as methods to assess innate immune immunoparalysis.

  8. Identification of immunoparalysis thresholds associated with clinical outcomes

    Time frame: Up to 28 days after intubation.

    Determination of threshold values of monocyte HLA-DR expression and TNF-α production after LPS stimulation associated with increased risk of ventilator-associated pneumonia and other ICU-acquired infections.

  9. Correlation between immunoparalysis and clinical outcomes

    Time frame: From ICU admission to day 90, depending on the clinical outcome assessed

    Correlation between the presence, duration, intensity, and trends of immunoparalysis and clinical outcomes, including ICU-acquired infections, duration of mechanical ventilation, vasopressor support, organ dysfunction (SOFA score), ICU and hospital length of stay, and survival status.

  10. Effect of macrolide therapy on immunoparalysis and infection outcomes

    Time frame: Up to 28 days after intubation.

    Correlation between macrolide treatment (e.g., clarithromycin) and changes in immunoparalysis parameters, as well as its correlation with the incidence of ventilator-associated pneumonia and ICU-acquired infections.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Intensity and Duration of Innate Immune System Immunoparalysis in the Pathophysiology of Ventilator-Associated Pneumonia in Mechanically Ventilated Elderly Patients

Acronym: IMP-VM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
May 19, 2026

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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