VAP - Ventilator Associated PneumoniaLUNG-I3NCT06073834
LUNG INFECTION IN ICU (LUNG-I3)
An observational study of VAP - Ventilator Associated Pneumonia, run by BioMérieux at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2023to 25 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- VAP - Ventilator Associated Pneumonia
- Keywords
- VAP - Ventilator Associated Pneumonia, Sepsis, Lung Infection, Broncho-alveolar Lavage, ICU
- Medical subject headings
- Pneumonia, Ventilator-Associated, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and at time of VAP diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start5 Dec 2023
- Primary completion24 Apr 2025
- Study completion25 Jun 2026
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073834
- Sponsor's protocol ID
- LUNG-I3
- Acronym
- LUNG-I3
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUNG INFECTION IN ICU
- ClinicalTrials.gov ID
- NCT06073834
- Acronym / sponsor ID
- LUNG-I3 / LUNG-I3
- Conditions
- VAP - Ventilator Associated Pneumonia
- Keywords
- VAP - Ventilator Associated Pneumonia, Sepsis, Lung Infection, Broncho-alveolar Lavage, ICU
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- All the following criteria
- Age 18 years or greater
- Severe ICU patients hospitalized for one of the above diseases:
- NAD > 0.1 µg/kg/min
- At least 2 SOFA criteria ≥ 2 points
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VAP - Ventilator Associated Pneumonia, run by BioMérieux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immune cells patterns in VAP (time frame: before and at time of VAP diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.