LUNG INFECTION in ICU (LUNG-I3)

Launched by BIOMÉRIEUX · Oct 3, 2023

Keywords

ClinConnect Summary

The LUNG-I3 clinical trial is focused on understanding how certain immune cells behave in patients with Ventilator-Associated Pneumonia (VAP), a lung infection that can occur in people on ventilators in the Intensive Care Unit (ICU). Researchers want to compare immune cells found in the blood with those in a fluid sample taken from the lungs, specifically looking at types of cells called alveolar macrophages and neutrophils, which are important for fighting infections. The study is currently recruiting participants who are 18 years or older and are severely ill in the ICU due to conditions like septic shock, severe trauma, or significant burns.

To participate in the trial, patients must meet specific health criteria, such as requiring certain medical support and having measurable signs of illness. However, those with certain conditions like chronic obstructive pulmonary disease (COPD), pregnancy, or weakened immune systems cannot join. Participants can expect to contribute to important research that may help improve the understanding and treatment of lung infections in critically ill patients. It's important to discuss with a healthcare provider if you or a loved one might be eligible and what involvement in the study would entail.

Gender

ALL

Eligibility criteria

• 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.