LUNG INFECTION IN ICU (LUNG-I3) (LUNG-I3)

LUNG INFECTION IN ICU

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

Study Overview

• Status: Not yet recruiting
• Conditions: VAP - Ventilator Associated Pneumonia

• Study Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

• Study Contact: Name: Jean-François LLITJOS; Phone Number: +33761568397; Email: jeanfrancois.llitjos@biomerieux.com
• Study Contact Backup: Name: Marie-Angelique CAZALIS; Phone Number: +33626807839; Email: marie-angelique.cazalis@biomerieux.com

Study Locations

• France
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
    • Contact: Anne-Claire Lukaszewicz, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ICU Adult patients hospitalized and managed for septic shock or severe trauma (including severe burn) and undergoing mechanical ventilation (within 24h of admission) with an expected length upper than 3 days.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune cells patterns in VAP	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.	before and at time of VAP diagnosis

Collaborators and Investigators

• Sponsor: BioMérieux

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ICU; Sepsis; Lung Infection; Broncho-alveolar Lavage; VAP - Ventilator Associated Pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: LUNG-I3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No