Pneumonia, Ventilator-AssociatedIMMUNAIXNCT06607055
Immunity Markers in Intensive Care Patients and Ventilator-associated Pneumonia
An observational study of Pneumonia, Ventilator-Associated, run by Centre Hospitalier Intercommunal Aix-Pertuis at 1 site in France.
Trial summary
The goal of this observational study is to show the direct correlation between the occurrence of recurrence of VAP and postagressive immunoparalysis, monitored by HLA-DR rate below litterature-acknowledged threshold, in a well conducted antibiotherapy context, in patient admitted in the Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Blood collection
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2023to Dec 2026
- 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: Patient admitted in the ICU of the CHIAP under mechanical ventilation and with infectious pneumonia
Who may be able to join
- Patient over 18 years old
- Patient admitted in the Intensive Care Unit of the CHIAP
- Patient under mechanical ventilation
- Patient with infectious pneumonia
- Informed Consent Form (ICF) obtained from the patient or emergency ICF obtained from close relatives
- Patient beneficiary of French social security, whatever the regime
Who cannot join
- Patient under 18 years old
- Patient with severe neutropenia (neutrophils < 0.5 G/L)
- Patient under immunosuppressive treatment
- Use of corticosteroids (intravenous or oral) prior to ICU admission
- Use of therapeutic antibodies
- Onco-hematological disease (e.g. lymphoma, leukemia...) under treatment or treated in the 5 years prior to inclusion
Show all 14Show fewer
- End of chemotherapy 6 months prior to inclusion
- Patients with innate or acquired immune deficiency (e.g., severe combined immunodeficiency, HIV or AIDS, at any stage)
- Patients with a decision to limit or discontinue active therapies, at the time of inclusion
- Patients with an estimated ICU stay of less than 48 hours
- Participation in an interventional study
- Patient deprived of their liberty
- Patient under tutorship or curatorship
- Pregnant or breastfeeding woman
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
Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, 13100
Laurent LEFEBVRE, 0442335650 ext. +33, llefebvre@ch-aix.fr
About this study
Official title: Monitoring of Immunity Markers in Intensive Care Patients and Link With Recurrence and Relapse of Ventilator-associated Pneumonia
The goal of this observational study is to show the direct correlation between the occurrence of recurrence of VAP and postagressive immunoparalysis, monitored by HLA-DR rate below litterature-acknowledged threshold, in a well conducted antibiotherapy context, in patient admitted in the Intensive Care Unit.
The main questions it aims to answer are:
- evaluation of the association between death and persistence of immunoplegia using HLA-DR monitoring
- search an association between immunoplegia depth and severity of the initial state of shock
- search an association between immunoplegia depth and viral reactivation
- compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence Blood samples will be taken from participants to HLA-DR dosage, at the time of inclusion and once a week then.
Read the detailed description
The occurrence of ICU-acquired infections in patients admitted to the intensive care unit (ICU) results in increased morbidity and mortality, increased length of stay in the ICU, and also clearly increased healthcare costs. The incidence of these infections fluctuates between 15% and 40%, depending on the study. A major problem in the ICU is the recurrence and relapse of ventilator-associated pneumonia (VAP), with increased exposure to antibiotics and a probable increase in average length of stay.
One of the possible hypothesis that could explain relapses/recurrences of VAP is incorrect conducted antibiotherapy. To prevent this, in the unit, we currently perform antibiotics pharmacological assays and adapt them to the antibiogram. Another possible explanation to treatment failure could be patients' postagressive immunoparalysis. It has clearly been demonstrated that postagressive immunoparalysis is a predisposing state to healthcare related infections.
Some markers can be used to monitor this immunoplegia state. Several studies have shown that low HLA-DR expression and reduced CD16 expression (polymorphonuclear neutrophils percentage) is associated with increased susceptibility to develop infections in the ICU.
Immunity monitoring could be an interesting tool to identify populations most at risk of developing healthcare-associated infections after a state of shock, and could become an interesting line of thinking for the use of immunomodulatory therapies. To best evaluate these therapies and find a place for them in the current arsenal, it is essential to integrate them into daily practice by linking them to a significant clinical event, such as recurrent healthcare-associated infections, despite properly conducted antibiotic treatment.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Blood collection
- 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.
Blood collectionDiagnostic test
HLA-DR dosage, at the time of inclusion and once a week then
| Study group | Role | What they receive |
|---|---|---|
| Interventional - blood collection | HLA-DR dosage, at the time of inclusion and once a week then Receives: Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a VAP recurrence/relapse
Number of occurrence of a VAP recurrence/relapse
Measured: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (4)
Viral reactivation
To search for association between immunoplegia depth and viral reactivation (CMV)
Measured: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
Association between immunoparalysis depth and state of shock severity within the first 24 hours
To search for association between immunoplegia depth and severity of the initial state of shock (lactatemia, amine dosage, SOFA score over 48 hours)
Measured: First 24 hours
Persistence of immunoparalysis during hospitalization and care-related infections
To compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence
Measured: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
HLA-DR nadir and link with care-related infections
To compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence
Measured: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start4 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-Pertuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent LEFEBVRE, Centre Hospitalier Intercommunal Aix-Pertuis
- Investigators
- Laurent LEFEBVRE, MD, Principal investigator, Centre Hospitalier Intercommunal Aix-Pertuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607055
- Sponsor's protocol ID
- 20232704-9
- Acronym
- IMMUNAIX
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Immunity Markers in Intensive Care Patients and Link With Recurrence and Relapse of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT06607055
- Acronym / sponsor ID
- IMMUNAIX / 20232704-9
- Conditions
- Pneumonia, Ventilator-Associated
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-PertuisUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
The goal of this observational study is to show the direct correlation between the occurrence of recurrence of VAP and postagressive immunoparalysis, monitored by HLA-DR rate below litterature-acknowledged threshold, in a well conducted antibiotherapy context, in patient admitted in the Intensive Care Unit.
The main questions it aims to answer are:
- evaluation of the association between death and persistence of immunoplegia using HLA-DR monitoring
- search an association between immunoplegia depth and severity of the initial state of shock
- search an association between immunoplegia depth and viral reactivation
- compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence Blood samples will be taken from participants to HLA-DR dosage, at the time of inclusion and once a week then.
Detailed description
The occurrence of ICU-acquired infections in patients admitted to the intensive care unit (ICU) results in increased morbidity and mortality, increased length of stay in the ICU, and also clearly increased healthcare costs. The incidence of these infections fluctuates between 15% and 40%, depending on the study. A major problem in the ICU is the recurrence and relapse of ventilator-associated pneumonia (VAP), with increased exposure to antibiotics and a probable increase in average length of stay.
One of the possible hypothesis that could explain relapses/recurrences of VAP is incorrect conducted antibiotherapy. To prevent this, in the unit, we currently perform antibiotics pharmacological assays and adapt them to the antibiogram. Another possible explanation to treatment failure could be patients' postagressive immunoparalysis. It has clearly been demonstrated that postagressive immunoparalysis is a predisposing state to healthcare related infections.
Some markers can be used to monitor this immunoplegia state. Several studies have shown that low HLA-DR expression and reduced CD16 expression (polymorphonuclear neutrophils percentage) is associated with increased susceptibility to develop infections in the ICU.
Immunity monitoring could be an interesting tool to identify populations most at risk of developing healthcare-associated infections after a state of shock, and could become an interesting line of thinking for the use of immunomodulatory therapies. To best evaluate these therapies and find a place for them in the current arsenal, it is essential to integrate them into daily practice by linking them to a significant clinical event, such as recurrent healthcare-associated infections, despite properly conducted antibiotic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional - blood collection | – | Diagnostic Test: Blood collectionHLA-DR dosage, at the time of inclusion and once a week then |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted in the ICU of the CHIAP under mechanical ventilation and with infectious pneumonia
Key inclusion criteria (6 listed)
- Patient over 18 years old
- Patient admitted in the Intensive Care Unit of the CHIAP
- Patient under mechanical ventilation
- Patient with infectious pneumonia
- Informed Consent Form (ICF) obtained from the patient or emergency ICF obtained from close relatives
Key exclusion criteria (14 listed)
- Patient under 18 years old
- Patient with severe neutropenia (neutrophils < 0.5 G/L)
- Patient under immunosuppressive treatment
- Use of corticosteroids (intravenous or oral) prior to ICU admission
- Use of therapeutic antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionHLA-DR dosage, at the time of inclusion and once a week then | Diagnostic test | Interventional - blood collection |
Primary outcome
Occurrence of a VAP recurrence/relapse
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
Number of occurrence of a VAP recurrence/relapse
4 secondary outcomes
Viral reactivation
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
Association between immunoparalysis depth and state of shock severity within the first 24 hours
Time frame: First 24 hours
Persistence of immunoparalysis during hospitalization and care-related infections
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
HLA-DR nadir and link with care-related infections
Time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Laurent LEFEBVRE, MD principal investigator
Centre Hospitalier Intercommunal Aix-Pertuis
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 Pneumonia, Ventilator-Associated, run by Centre Hospitalier Intercommunal Aix-Pertuis 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 6 inclusion and 14 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 26 Aug 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 Laurent LEFEBVRE, MD (0442335650 ext. +33, llefebvre@ch-aix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a VAP recurrence/relapse (time frame: From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months). 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 26 Aug 2026.