Status:
RECRUITING
LUNG INFECTION in ICU (LUNG-I3)
Lead Sponsor:
BioMérieux
Conditions:
VAP - Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06073834
Start Date
December 5 2023
End Date
June 1 2027
Last Update
February 12 2025
Active Locations (1)
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1
Hopital Edouard Herriot
Lyon, France, 69003