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LUNG INFECTION in ICU (LUNG-I3)

LUNG INFECTION in ICU

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06073834
Acronym
LUNG-I3
Enrollment
68
Registered
2023-10-10
Start date
2023-12-05
Completion date
2027-06-30
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VAP - Ventilator Associated Pneumonia

Keywords

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

Brief summary

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

Interventions

None listed

Sponsors

BioMérieux
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
immune cells patterns in VAPbefore and at time of VAP diagnosisThe 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.

Countries

France

Contacts

Primary ContactJean-François LLITJOS
jeanfrancois.llitjos@biomerieux.com+33761568397
Backup ContactMarie-Angelique CAZALIS
marie-angelique.cazalis@biomerieux.com+33626807839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026