Ireland
--:--IST
Recruiting Observational

LUNG INFECTION in ICU (LUNG-I3)

NCT06073834 · tracked via the Priya Life Science France tracker
Sponsor
BioMérieux
Phase
Observational
Started
2023-12-05
Last updated
2025-02-12

Condition(s) studied

VAP - Ventilator Associated Pneumonia

Study summary

objective of LUNG-I3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (BAL) fluid after an infection, with a special focus on alveolar macrophages and neutrophils

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: All the following criteria * Age 18 years or greater * Severe ICU patients hospitalized for one of the above diseases: * Septic shock (requirement of vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia) caused either by pneumonia (n=20) or another source n=20) * Severe trauma (level I and II), Injury Severity Score ≥ 25 OR * Burn with TBSA over 20% * NAD \> 0.1 µg/kg/min * At least 2 SOFA criteria ≥ 2 points Exclusion Criteria: * Aspiration pneumonia * Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this includes in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1121-8 of the French Public Health Code.) * COPD * Smoke inhalation in burn patients * Participation in an intervention study * Pregnant or breastfeeding women * Immunocompromised patients, defined as * patients with solid tumors with chemotherapy in the last 3 months or a progressive metastatic disease * hematologic malignancies * solid organ transplantation * HIV infection with or without AIDS * treatment with corticosteroids (\> 3 months at any dosage or ≥ 1 mg/kg prednisone equivalent per day for \> 7 day) * treatment with other immunosuppressive drugs.

Primary outcome measure(s)

  • immune cells patterns in VAP — before and at time of VAP diagnosis
    The primary endpoint will be to describe and compare the distribution of immune cells within the lung and the blood before VAP diagnosis (VAP prediction) and at the time of VAP diagnosis.

Trial sites (1)

FacilityCityRegionStatus
Hopital Edouard Herriot Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06073834 on ClinicalTrials.gov ↗ ← All trials in France