LUNG INFECTION in ICU (LUNG-I3)

Recruiting

• Conditions: VAP - Ventilator Associated Pneumonia

• Registration Number: NCT06073834
• Lead Sponsor: BioMérieux

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2023-12-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-04
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Hopital Edouard Herriot; 🇫🇷 Lyon, France