- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436780
B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia) (OLYMPE)
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
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Safirah Akowanou
- Phone Number: +33555058755
- Email: safirah.akowanou@chu-limoges.fr
Study Contact Backup
- Name: Abdeslam BEN TALEB
- Phone Number: +33555058616
- Email: abdeslam.bentaleb@chu-limoges.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Julien VAIDIE, Dr, University Hospital, Limoges
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87RI25_0020 (OLYMPE)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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