LUNG INFECTION in ICU (LUNG-I3)

bioMérieux

Status: Enrolling

Conditions: VAP - Ventilator Associated Pneumonia

Study type: Observational

Funder types: Industry

Identifiers

NCT06073834

LUNG-I3

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.