Ventilator-associated PneumoniaOLYMPENCT07436780
B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
An observational study of Ventilator-associated Pneumonia, run by University Hospital, Limoges at 1 site in France.
Trial summary
Diagnosis of VAP relies on a set of non-specific clinical, biological, and imaging criteria. Understanding host-pathogen interactions and the mechanisms of deregulations leading to infection of pulmonary tissue appears essential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2026to 11 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients of Limoges University Hospital admitted to emergency room
Who may be able to join
- Adult patients (≥18 years old), admitted to intensive care under mechanical ventilation for an estimated duration of at least 5 days.
Who cannot join
- Patients admitted for an infectious pneumonia or presenting with acute respiratory distress syndrome (ARDS). Patients in aplasia (leukocytes < 0.5 gigal/L).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Limoges
Limoges, 87042
Julien VAIDIE, 0555056022 ext. +33, Julien.VAIDIE@chu-limoges.fr
Julien VAIDIE
About this study
Official title: Pilot Study Describing B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
Diagnosis of VAP relies on a set of non-specific clinical, biological, and imaging criteria.
Understanding host-pathogen interactions and the mechanisms of deregulations leading to infection of pulmonary tissue appears essential.
The aim is to qualitatively describe the B lymphocyte populations present in the pulmonary microenvironment of patients admitted to intensive care and requiring invasive mechanical ventilation
Read the detailed description
The study of the immune system and host-pathogen interactions is the subject of extensive research to improve the understanding of pathophysiology, leading to more precise diagnostic criteria, and considering preventive or curative treatments while limiting the use of anti-infective molecules. Understanding host-pathogen interactions and the mechanisms of deregulations leading to infection of pulmonary tissue seems essential. The study of T lymphocyte populations has already been the focus of numerous investigations. However, regarding the humoral immune response, B lymphocyte populations and their roles have so far been little explored in this context. Nevertheless, the presence of B lymphocytes in pulmonary tissue has been proven, particularly in infectious, postinfectious, or postvaccination contexts, but currently, there are no published studies regarding the B lymphocytes role in the pathophysiology of VAP (Ventilator-Associated Pneumonia).
Respiratory samples (endotracheal aspirates) will be collected from patients under mechanical ventilation on the day of intubation (D0), the day before extubation (Dext), and the day of VAP diagnosis (DVAP) for patients who will develop it. The samples will be stored and then analyzed by flow cytometry.
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- ventilator-associated pneumonia, Intensive care medicine, host-pathogen interaction, humoral immunity
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ventilator Associated Pneumonia (VAP) | Patient who developped Ventilator Associated Pneumonia (VAP) under mechanical ventilation | |
| Without Ventilator Associated Pneumonia | Patient who did not develop Ventilator Associated Pneumonia (VAP) under mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative description of B lymphocyte populations by flow cytometry analysis with specific antibodies
To qualitatively describe the B lymphocyte populations in the endotracheal aspirates of patients admitted to intensive care and requiring invasive mechanical ventilation.
B lymphocyte subpopulations will be described using a flow cytometry method using antibodies targeting the following markers: CD93, CD62L, CD14, CXCR4, CD32, CD27, CD38, CD138, CD3, CD10, CD19, CD20, kappa light chains, lambda light chains.
Measured: At the inclusion (T1), at diagnosis (T2 on the day of VAP diagnosis for patient who will develop it, on average 72 hours after the inclusion), at the end of the study (T3 on the day before extubation, on average 5 days after the inclusion)
Secondary outcomes (1)
Quantitative description of B lymphocyte populations by flow cytometry analysis with specific antibodies
To quantitatively describe the B lymphocyte populations in the endotracheal aspirates of patients admitted to intensive care, requiring invasive mechanical ventilation, and presenting ventilator associated pneumonia (VAP).
B lymphocyte subpopulations will be described using a flow cytometry method using antibodies targeting the following markers: CD93, CD62L, CD14, CXCR4, CD32, CD27, CD38, CD138, CD3, CD10, CD19, CD20, kappa light chains, lambda light chains
Measured: At the inclusion (T1), at diagnosis (T2 on the day of VAP diagnosis for patient who will develop it, on average 72 hours after the inclusion), at the end of the study (T3 on the day before extubation, on average 5 days after the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start12 Jan 2026
- Primary completion11 Jul 2027 (estimated)
- Study completion11 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien VAIDIE, Dr, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436780
- Sponsor's protocol ID
- 87RI25_0020 (OLYMPE)
- Acronym
- OLYMPE
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Describing B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
- ClinicalTrials.gov ID
- NCT07436780
- Acronym / sponsor ID
- OLYMPE / 87RI25_0020 (OLYMPE)
- Conditions
- Ventilator-associated Pneumonia
- Keywords
- ventilator-associated pneumonia, Intensive care medicine, host-pathogen interaction, humoral immunity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 11 Jul 2027 (estimated)
- Study completion
- 11 Jul 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
Diagnosis of VAP relies on a set of non-specific clinical, biological, and imaging criteria.
Understanding host-pathogen interactions and the mechanisms of deregulations leading to infection of pulmonary tissue appears essential.
The aim is to qualitatively describe the B lymphocyte populations present in the pulmonary microenvironment of patients admitted to intensive care and requiring invasive mechanical ventilation
Detailed description
The study of the immune system and host-pathogen interactions is the subject of extensive research to improve the understanding of pathophysiology, leading to more precise diagnostic criteria, and considering preventive or curative treatments while limiting the use of anti-infective molecules. Understanding host-pathogen interactions and the mechanisms of deregulations leading to infection of pulmonary tissue seems essential. The study of T lymphocyte populations has already been the focus of numerous investigations. However, regarding the humoral immune response, B lymphocyte populations and their roles have so far been little explored in this context. Nevertheless, the presence of B lymphocytes in pulmonary tissue has been proven, particularly in infectious, postinfectious, or postvaccination contexts, but currently, there are no published studies regarding the B lymphocytes role in the pathophysiology of VAP (Ventilator-Associated Pneumonia).
Respiratory samples (endotracheal aspirates) will be collected from patients under mechanical ventilation on the day of intubation (D0), the day before extubation (Dext), and the day of VAP diagnosis (DVAP) for patients who will develop it. The samples will be stored and then analyzed by flow cytometry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilator Associated Pneumonia (VAP) | – | –Patient who developped Ventilator Associated Pneumonia (VAP) under mechanical ventilation |
| Without Ventilator Associated Pneumonia | – | –Patient who did not develop Ventilator Associated Pneumonia (VAP) under mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Limoges University Hospital admitted to emergency room
Key inclusion criteria (1 listed)
- Adult patients (≥18 years old), admitted to intensive care under mechanical ventilation for an estimated duration of at least 5 days.
Key exclusion criteria (1 listed)
- Patients admitted for an infectious pneumonia or presenting with acute respiratory distress syndrome (ARDS). Patients in aplasia (leukocytes < 0.5 gigal/L).
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
Qualitative description of B lymphocyte populations by flow cytometry analysis with specific antibodies
Time frame: At the inclusion (T1), at diagnosis (T2 on the day of VAP diagnosis for patient who will develop it, on average 72 hours after the inclusion), at the end of the study (T3 on the day before extubation, on average 5 days after the inclusion)
To qualitatively describe the B lymphocyte populations in the endotracheal aspirates of patients admitted to intensive care and requiring invasive mechanical ventilation. B lymphocyte subpopulations will be described using a flow cytometry method using antibodies targeting the following markers: CD93, CD62L, CD14, CXCR4, CD32, CD27, CD38, CD138, CD3, CD10, CD19, CD20, kappa light chains, lambda light chains.
1 secondary outcome
Quantitative description of B lymphocyte populations by flow cytometry analysis with specific antibodies
Time frame: At the inclusion (T1), at diagnosis (T2 on the day of VAP diagnosis for patient who will develop it, on average 72 hours after the inclusion), at the end of the study (T3 on the day before extubation, on average 5 days after the inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Julien VAIDIE, Dr principal investigator
University Hospital, Limoges
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 Ventilator-associated Pneumonia, run by University Hospital, Limoges 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safirah Akowanou (+33555058755, safirah.akowanou@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative description of B lymphocyte populations by flow cytometry analysis with specific antibodies (time frame: At the inclusion (T1), at diagnosis (T2 on the day of VAP diagnosis for patient who will develop it, on average 72 hours after the inclusion), at the end of the study (T3 on the day before extubation, on average 5 days after the inclusion)). 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 24 Sep 2026.