Intubated ICU PatientsIMP-VMNCT07551258
Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients
An observational study of Intubated ICU Patients and Ventilator Associated Pneumonia ( VAP), run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
This prospective observational cohort study aims to evaluate the role of innate immune immunoparalysis in the development of ventilator-associated pneumonia (VAP) in critically ill mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubated ICU Patients, Ventilator Associated Pneumonia ( VAP), Immunoparalysis
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2026to 31 Jul 2028
- How long will I take part?
- 90 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically ill adult patients requiring invasive mechanical ventilation for more than 48 hours and admitted to the Intensive Care Unit will be consecutively screened for inclusion. The study will include two patient cohorts (≥65 years and 18-64 years), as well as a cohort of healthy adult volunteers serving as controls.
Who may be able to join
- ≥18 years
- Mechanical ventilation expected >48h
- Intubation between 24h pre- and 48h post- ICU admission
- Informed consent
Who cannot join
- Known severe immunosuppression, including primary immunodeficiency disorders, advanced HIV infection (AIDS), active hematological malignancy under treatment, recent chemotherapy or immunosuppressive therapy
- High dose steroids at immunosuppressive doses
- Active autoimmune disease
- Pregnancy
- End-of-life situation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Servei de medicina intensiva, Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Joan Sabater Riera, MD, PhD, +34 932607646, jsabater@bellvitgehospital.cat
Arnau Ulsamer, PhD, +34 936073800 ext. 3068, aulsamer@idibell.cat
About this study
Official title: Intensity and Duration of Innate Immune System Immunoparalysis in the Pathophysiology of Ventilator-Associated Pneumonia in Mechanically Ventilated Elderly Patients
This prospective observational cohort study aims to evaluate the role of innate immune immunoparalysis in the development of ventilator-associated pneumonia (VAP) in critically ill mechanically ventilated patients. Immunoparalysis will be assessed through monocyte HLA-DR expression and ex vivo lipopolysaccharide (LPS)-stimulated TNF-α production.
The study will include three cohorts: elderly patients (≥65 years), younger adults (<65 years), and healthy controls. The primary objective is to determine whether the presence, duration, intensity, and trend of immunoparalysis are associated with the incidence of VAP and other ICU-acquired infections. Secondary objectives include characterization of immunoparalysis dynamics, comparison of measurement methods, and evaluation of clinical outcomes.
- Keywords
- invasive mechanical ventilation, LPS stimulation, HLA-DR, innate immunity, ICU-acquired infections
- 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 |
|---|---|---|
| Elderly Mechanically Ventilated Patients (≥65 years) | Critically ill patients aged 65 years or older requiring invasive mechanical ventilation for more than 48 hours. This is the primary study cohort in which innate immune immunoparalysis will be assessed and its association with ventilator-associated pneumonia will be analyzed. | |
| Adult Mechanically Ventilated Patients (<65 years) | Critically ill patients aged 18 to 64 years requiring invasive mechanical ventilation for more than 48 hours, included as a comparison cohort to evaluate age-related differences in immunoparalysis. | |
| Healthy Non-Intubated Controls | Healthy adult volunteers without acute illness and not requiring mechanical ventilation. This group, assessed at a single time point, will serve as a reference population for baseline immunological parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia (VAP)
Occurrence of ventilator-associated pneumonia in critically ill mechanically ventilated patients, defined according to standard clinical, radiological, and microbiological criteria.
Measured: Up to 28 days after intubation
Secondary outcomes (10)
Incidence of ICU-acquired infections
Occurrence of secondary infections acquired during ICU stay, including device-related infections and other nosocomial infections diagnosed according to standard clinical, microbiological, and radiological criteria.
Measured: Up to 28 days after intubation
Duration of invasive mechanical ventilation
Total number of days under invasive mechanical ventilation during ICU stay.
Measured: Up to 28 Days after intubation
All-cause mortality at 28 days
Death from any cause within 28 days after ICU admission.
Measured: 28 days after intubation
Evolution of Sequential Organ Failure Assessment (SOFA) score
Change in SOFA score over time during ICU stay as a measure of organ dysfunction trajectory.
Measured: From ICU admission to day 15 or ICU discharge, whichever occurs first.
Prevalence of innate immune immunoparalysis at ICU admission
Proportion of patients presenting innate immune immunoparalysis at ICU admission, defined by reduced monocyte HLA-DR expression (<5000 antibodies bound per cell [AB/C]) and/or decreased TNF-α production after ex vivo lipopolysaccharide (LPS) stimulation (<200 pg/mL), based on previously reported thresholds.
Measured: At ICU admission (baseline)
Temporal evolution of innate immune immunoparalysis
Changes over time in innate immune immunoparalysis assessed by serial measurements of monocyte HLA-DR expression and ex vivo LPS-stimulated TNF-α production, including intensity, duration, and trends.
Measured: Baseline, 24 hours, day 3, and day 5 after intubation
Agreement between HLA-DR expression and LPS-stimulated TNF-α production
Concordance between monocyte HLA-DR expression and ex vivo LPS-stimulated TNF-α production as methods to assess innate immune immunoparalysis.
Measured: From baseline to day 5 after intubation.
Identification of immunoparalysis thresholds associated with clinical outcomes
Determination of threshold values of monocyte HLA-DR expression and TNF-α production after LPS stimulation associated with increased risk of ventilator-associated pneumonia and other ICU-acquired infections.
Measured: Up to 28 days after intubation.
Correlation between immunoparalysis and clinical outcomes
Correlation between the presence, duration, intensity, and trends of immunoparalysis and clinical outcomes, including ICU-acquired infections, duration of mechanical ventilation, vasopressor support, organ dysfunction (SOFA score), ICU and hospital length of stay, and survival status.
Measured: From ICU admission to day 90, depending on the clinical outcome assessed
Effect of macrolide therapy on immunoparalysis and infection outcomes
Correlation between macrolide treatment (e.g., clarithromycin) and changes in immunoparalysis parameters, as well as its correlation with the incidence of ventilator-associated pneumonia and ICU-acquired infections.
Measured: Up to 28 days after intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion28 May 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubated ICU PatientsStudies 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
- 170 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sabater-Riera, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551258
- Sponsor's protocol ID
- IMP-VM
- Acronym
- IMP-VM
- Status last verified
- May 2026
- First submitted
- 19 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity and Duration of Innate Immune System Immunoparalysis in the Pathophysiology of Ventilator-Associated Pneumonia in Mechanically Ventilated Elderly Patients
- ClinicalTrials.gov ID
- NCT07551258
- Acronym / sponsor ID
- IMP-VM / IMP-VM
- Keywords
- invasive mechanical ventilation, LPS stimulation, HLA-DR, innate immunity, ICU-acquired infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 28 May 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Apr 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.
This prospective observational cohort study aims to evaluate the role of innate immune immunoparalysis in the development of ventilator-associated pneumonia (VAP) in critically ill mechanically ventilated patients. Immunoparalysis will be assessed through monocyte HLA-DR expression and ex vivo lipopolysaccharide (LPS)-stimulated TNF-α production.
The study will include three cohorts: elderly patients (≥65 years), younger adults (<65 years), and healthy controls. The primary objective is to determine whether the presence, duration, intensity, and trend of immunoparalysis are associated with the incidence of VAP and other ICU-acquired infections. Secondary objectives include characterization of immunoparalysis dynamics, comparison of measurement methods, and evaluation of clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly Mechanically Ventilated Patients (≥65 years) | – | –Critically ill patients aged 65 years or older requiring invasive mechanical ventilation for more than 48 hours. This is the primary study cohort in which innate immune immunoparalysis will be assessed and its association with ventilator-associated pneumonia will be analyzed. |
| Adult Mechanically Ventilated Patients (<65 years) | – | –Critically ill patients aged 18 to 64 years requiring invasive mechanical ventilation for more than 48 hours, included as a comparison cohort to evaluate age-related differences in immunoparalysis. |
| Healthy Non-Intubated Controls | – | –Healthy adult volunteers without acute illness and not requiring mechanical ventilation. This group, assessed at a single time point, will serve as a reference population for baseline immunological parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients requiring invasive mechanical ventilation for more than 48 hours and admitted to the Intensive Care Unit will be consecutively screened for inclusion. The study will include two patient cohorts (≥65 years and 18-64 years), as well as a cohort of healthy adult volunteers serving as controls.
Key inclusion criteria (4 listed)
- ≥18 years
- Mechanical ventilation expected >48h
- Intubation between 24h pre- and 48h post- ICU admission
- Informed consent
Key exclusion criteria (5 listed)
- Known severe immunosuppression, including primary immunodeficiency disorders, advanced HIV infection (AIDS), active hematological malignancy under treatment, recent chemotherapy or immunosuppressive therapy
- High dose steroids at immunosuppressive doses
- Active autoimmune disease
- Pregnancy
- End-of-life situation
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
Incidence of ventilator-associated pneumonia (VAP)
Time frame: Up to 28 days after intubation
Occurrence of ventilator-associated pneumonia in critically ill mechanically ventilated patients, defined according to standard clinical, radiological, and microbiological criteria.
10 secondary outcomes
Incidence of ICU-acquired infections
Time frame: Up to 28 days after intubation
Duration of invasive mechanical ventilation
Time frame: Up to 28 Days after intubation
All-cause mortality at 28 days
Time frame: 28 days after intubation
Evolution of Sequential Organ Failure Assessment (SOFA) score
Time frame: From ICU admission to day 15 or ICU discharge, whichever occurs first.
Prevalence of innate immune immunoparalysis at ICU admission
Time frame: At ICU admission (baseline)
Temporal evolution of innate immune immunoparalysis
Time frame: Baseline, 24 hours, day 3, and day 5 after intubation
Agreement between HLA-DR expression and LPS-stimulated TNF-α production
Time frame: From baseline to day 5 after intubation.
Identification of immunoparalysis thresholds associated with clinical outcomes
Time frame: Up to 28 days after intubation.
Correlation between immunoparalysis and clinical outcomes
Time frame: From ICU admission to day 90, depending on the clinical outcome assessed
Effect of macrolide therapy on immunoparalysis and infection outcomes
Time frame: Up to 28 days after intubation.
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 19 May 2026.
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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.
Servei de medicina intensiva, Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
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 Intubated ICU Patients and Ventilator Associated Pneumonia ( VAP), run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 4 inclusion and 5 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 19 May 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated pneumonia (VAP) (time frame: Up to 28 days after intubation). 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 19 May 2026.