Assessing lung infection differences in ICU patients

LUNG INFECTION in ICU

This study is testing how different immune cells in the blood and lungs of ICU patients with ventilator-associated pneumonia respond to infection to help improve future treatments.

Quick facts

• Study type: Observational
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioMérieux (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Lyon)
• Trial ID: NCT06073834 on ClinicalTrials.gov

What this trial studies

The LUNG-I3 study aims to evaluate the quantitative and functional differences in immune cells found in blood and bronchoalveolar lavage (BAL) fluid in patients suffering from ventilator-associated pneumonia (VAP) in the ICU. The focus is particularly on analyzing alveolar macrophages and neutrophils to understand their roles during infection. This observational study will involve severe ICU patients who meet specific criteria related to septic shock, severe trauma, or significant burns. The findings could provide insights into the immune response in critically ill patients and inform future treatment strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are ICU patients aged 18 years or older with severe conditions such as septic shock, severe trauma, or significant burns.

Not a fit: Patients with aspiration pneumonia or those unable to provide valid consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of immune responses in lung infections, potentially leading to improved treatment protocols for ICU patients.

How similar studies have performed: While similar studies have explored immune responses in lung infections, this specific approach focusing on BAL fluid and immune cell differences is relatively novel.

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.

Where this trial is running

Lyon

• Hopital Edouard Herriot — Lyon, France (Recruiting)

Study contacts

• Study coordinator: Jean-François LLITJOS

Conditions VAP - Ventilator Associated Pneumonia; Sepsis; Lung Infection; Broncho-alveolar Lavage; ICU