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NCT Number: NCT06073834

LUNG INFECTION in ICU (LUNG-I3)

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Edouard Herriot

Lyon, 69003, France

Location status: Recruiting

Location contact

Anne-Claire Lukaszewicz, PU-PH

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. immune cells patterns in VAP

    Time frame: before and at time of VAP diagnosis

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François LLITJOS

CONTACT

[email protected]

+33761568397

Marie-Angelique CAZALIS

CONTACT

[email protected]

+33626807839

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Registry information

Official study title

LUNG INFECTION in ICU

Acronym: LUNG-I3

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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