Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients
Official title: Intensity and Duration of Innate Immune System Immunoparalysis in the Pathophysiology of Ventilator-Associated Pneumonia in Mechanically Ventilated Elderly Patients
Run by Hospital Universitari de Bellvitge · NCT07551258 · Data updated 2026-11-12
This study tests whether signs of innate immune immunoparalysis in adults on ventilators are linked to developing ventilator-associated pneumonia (VAP).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 28, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07551258 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older who are expected to require mechanical ventilation for more than 48 hours after intubation in the ICU.
✕Probably not a fit
Patients without evidence of immunoparalysis or whose immunologic profile does not relate to VAP risk may not benefit from any change in care based on this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational cohort study tracks adults on mechanical ventilation to see if markers of innate immune dysfunction, such as monocyte HLA-DR expression and ex vivo LPS-induced TNF-α production, correlate with VAP and other ICU-acquired infections. Three groups are studied: elderly (≥65), younger adults (<65), and healthy controls. The primary goal is to understand how the presence, duration, intensity, and trends of immunoparalysis relate to infection risk, while secondary aims explore measurement methods and clinical outcomes. No interventions are applied; data are collected from standard clinical care with laboratory assessments to characterize immune status over time.
Why it matters
Potential benefit: If successful, the findings could help predict which patients are at higher risk for VAP and guide future strategies to prevent ICU-acquired infections.
How similar studies have gone: Previous work has shown associations between innate immune markers and infection risk in critical illness, but this study adds longitudinal assessment and a distinct elderly cohort.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Servei de medicina intensiva, Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.