LUNG INFECTION IN ICU (LUNG-I3)

VAP - Ventilator Associated Pneumonia Clinical Trial

— LUNG-I3  

Official title:

LUNG INFECTION IN ICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06073834
• Other study ID #: LUNG-I3
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: BioMérieux
• Contact: Jean-François LLITJOS
• Phone: +33761568397
• Email: jeanfrancois.llitjos[@]biomerieux.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• VAP - Ventilator Associated Pneumonia

Locations

Country	Name	City	State
France	Hopital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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