B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia) (OLYMPE)

February 23, 2026 updated by: University Hospital, Limoges

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of Limoges University Hospital admitted to emergency room

Description

Inclusion Criteria:

  • Adult patients (≥18 years old), admitted to intensive care under mechanical ventilation for an estimated duration of at least 5 days.

Exclusion Criteria:

  • Patients admitted for an infectious pneumonia or presenting with acute respiratory distress syndrome (ARDS). Patients in aplasia (leukocytes < 0.5 gigal/L).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)

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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Limoges

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julien VAIDIE, Dr, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 87RI25_0020 (OLYMPE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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