B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ventilator-associated Pneumonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study Describing B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
Overview
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.
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- 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)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07436780 · 87RI25_0020 (OLYMPE)