Ventilator Acquired PneumoniaClusterVAPNCT07245888
ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-associated Pneumonia
An observational study of Ventilator Acquired Pneumonia and Mechanical Ventilation Complication, run by Region Skane at 4 sites in 3 countries.
Trial summary
Ventilator-associated pneumonia (VAP) is a common and serious infection in patients receiving mechanical ventilation in intensive care units. Current diagnostic methods are imprecise, leading to unnecessary antibiotic use and delayed treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Acquired Pneumonia, Mechanical Ventilation Complication
- How many people
- 400 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 May 2026to Dec 2027
- 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: Adult patients (≥18 years) admitted to intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom who are receiving invasive mechanical ventilation and undergo bronchoalveolar lavage (BAL) or mini-BAL for clinical suspicion of lower respiratory tract infection. Patients are enrolled at the time of sampling and followed for 30-day outcomes. No experimental interventions are administered; all patients receive standard care.
Who may be able to join
- Adult patients (≥18 years) admitted to an intensive care unit (ICU). Receiving invasive mechanical ventilation. Undergoing bronchoalveolar lavage (BAL) or mini-BAL on clinical indication for suspected lower respiratory tract infection.
- New or worsening clinical signs compatible with lower respiratory tract infection within the preceding 24 hours, defined as the treating clinician's suspicion plus at least one of:
- Body temperature >38 °C or <36 °C. Visually purulent tracheal secretions. Signs of reduced oxygenation (e.g., increased FiO₂ and/or decreased arterial pO₂, increased positive end-expiratory pressure or driving pressure).
- Request for chest radiograph to investigate infection or new infiltrate. Initiation of antibiotic therapy targeting lower respiratory tract infection.
Who cannot join
- BAL or mini-BAL performed solely for screening without suspicion of infection. Concurrent enrolment in the VAPmarkers study (reserved for external validation).
- Age <18 years. Any condition that, in the opinion of the investigator, would preclude safe participation or confound study objectives.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Sweden2 sites, 2 recruiting
- Recruiting
Skånes universitetssjukhus
Lund
Magnus Paulsson
- Recruiting
Karolinska universitetssjukhuset
Stockholm
Johan Petersson, MD PhD
Portugal1 site, 1 recruiting
- Not yet recruiting
Hospital de São Francisco Xavier
Lisbon
Pedro Povoa
About this study
Official title: Endotyping of Ventilator-associated Pneumonia With Proteomics on Bronchoalveolar Lavage for Improved Diagnosis, the ClusterVAP Study
Ventilator-associated pneumonia (VAP) is a common and serious infection in patients receiving mechanical ventilation in intensive care units. Current diagnostic methods are imprecise, leading to unnecessary antibiotic use and delayed treatment. The ClusterVAP study aims to identify biologically and clinically distinct subgroups of patients with suspected VAP by analyzing proteins in bronchoalveolar lavage (BAL) fluid using advanced proteomic techniques. This multicentre observational study will enroll approximately 400 adult patients from intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom. BAL or mini-BAL samples collected for clinical reasons will be analyzed to define "pneumoclusters" and explore their association with patient outcomes. The study will also identify candidate biomarkers that could support future diagnostic tools. No experimental treatments are given; all patients receive standard care. Results may improve diagnostic accuracy and guide personalized treatment strategies for critically ill patients.
Read the detailed description
ClusterVAP is an exploratory, observational, prospective, multicentre cross-sectional study designed to identify biologically and clinically distinct subgroups ("pneumoclusters") among patients with suspected ventilator-associated pneumonia (VAP). The study will enroll approximately 400 adult patients admitted to intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom who are receiving mechanical ventilation and undergo bronchoalveolar lavage (BAL) or mini-BAL for clinical reasons.
Residual BAL supernatant will be processed for proteomic analysis using liquid chromatography tandem mass spectrometry (LC-MS/MS). Unsupervised consensus clustering will be applied to proteomic data, alone and in combination with clinical and microbiological variables, to define pneumoclusters. These clusters will be characterized by clinical features, microbiology, and radiology, and compared for 30-day outcomes including mortality, ventilator-free days, antibiotic-free days, ICU-free days, and hospital-free days. Differential protein abundance analysis will be used to identify candidate biomarkers for pragmatic cluster assignment.
Data will be collected in electronic case report forms hosted in REDCap, with built-in quality checks. All data will be pseudonymized, and biological samples will be stored under controlled conditions for up to ten years for confirmatory analyses. No experimental interventions are administered; all patients receive standard care. The study has been approved by the Swedish Ethical Review Authority (Dnr 2025-04564-01) and equivalent bodies in participating countries. Results will be disseminated through peer-reviewed publications and scientific conferences, with statistical code shared for transparency.
- Keywords
- VAP, endotyping, mini-BAL
- 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 |
|---|---|---|
| Patients with suspected ventilator-associated pneumonia | Adult ICU patients receiving mechanical ventilation who undergo bronchoalveolar lavage (BAL) or mini-BAL for clinical suspicion of lower respiratory tract infection. Residual BAL fluid will be analyzed using proteomic profiling to identify biological subgroups ("pneumoclusters"). No experimental intervention is administered; all patients receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of patients into biologically distinct clusters ("pneumoclusters") based on BAL proteomic data
Unsupervised consensus clustering of bronchoalveolar lavage (BAL) proteomic profiles, alone and in combination with clinical and microbiological variables, will be performed to classify patients with suspected ventilator-associated pneumonia into biologically distinct clusters ("pneumoclusters"). The number of clusters, the number of patients per cluster, and key distinguishing features will be reported.
Measured: Day 0 (at enrolment)
Secondary outcomes (5)
30-day all-cause mortality
Mortality status compared across identified clusters.
Measured: 30 days after enrolment
Ventilator-free days
Number of days alive and free from invasive mechanical ventilation.
Measured: 30 days after enrolment
Antibiotic-free days
Number of days alive and not receiving systemic antibiotics.
Measured: 30 days after enrolment
ICU-free days
Number of days alive and not in an intensive care unit.
Measured: 30 days after enrolment
Hospital-free days
Number of days alive and not hospitalized.
Measured: 30 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, NOVA Medical School, Copenhagen University Hospital, Rigshospitalet, Karolinska University Hospital, University Hospital, Limoges, King's College Hospital NHS Trust, Umeå University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245888
- Sponsor's protocol ID
- 2025-04564-01
- Other IDs
- 2025
- Acronym
- ClusterVAP
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results will be made available upon reasonable request to the corresponding author, subject to approval by relevant ethics committees and execution of appropriate data transfer agreements. Statistical code will be shared alongside the main publication. No genetic data will be shared.
Publications
Sjovall F, Povoa P, Petersson J, Koulenti D, Hernandez Padilla AC, Vaidie J, Lind A, Boetius Hertz F, Paulsson M. ClusterVAP: study protocol for multicentre proteomic endotyping of ventilator-associated pneumonia. BMJ Open Respir Res. 2026 Mar 9;13(1):e003830. doi: 10.1136/bmjresp-2025-003830.
PubMed 41802817
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotyping of Ventilator-associated Pneumonia With Proteomics on Bronchoalveolar Lavage for Improved Diagnosis, the ClusterVAP Study
- ClinicalTrials.gov ID
- NCT07245888
- Acronym / sponsor ID
- ClusterVAP / 2025-04564-01
- Keywords
- VAP, endotyping, mini-BAL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, NOVA Medical School, Copenhagen University Hospital, Rigshospitalet, Karolinska University Hospital, University Hospital, Limoges, King's College Hospital NHS Trust, Umeå University
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Nov 2025 (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.
Ventilator-associated pneumonia (VAP) is a common and serious infection in patients receiving mechanical ventilation in intensive care units. Current diagnostic methods are imprecise, leading to unnecessary antibiotic use and delayed treatment. The ClusterVAP study aims to identify biologically and clinically distinct subgroups of patients with suspected VAP by analyzing proteins in bronchoalveolar lavage (BAL) fluid using advanced proteomic techniques. This multicentre observational study will enroll approximately 400 adult patients from intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom. BAL or mini-BAL samples collected for clinical reasons will be analyzed to define "pneumoclusters" and explore their association with patient outcomes. The study will also identify candidate biomarkers that could support future diagnostic tools. No experimental treatments are given; all patients receive standard care. Results may improve diagnostic accuracy and guide personalized treatment strategies for critically ill patients.
Detailed description
ClusterVAP is an exploratory, observational, prospective, multicentre cross-sectional study designed to identify biologically and clinically distinct subgroups ("pneumoclusters") among patients with suspected ventilator-associated pneumonia (VAP). The study will enroll approximately 400 adult patients admitted to intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom who are receiving mechanical ventilation and undergo bronchoalveolar lavage (BAL) or mini-BAL for clinical reasons.
Residual BAL supernatant will be processed for proteomic analysis using liquid chromatography tandem mass spectrometry (LC-MS/MS). Unsupervised consensus clustering will be applied to proteomic data, alone and in combination with clinical and microbiological variables, to define pneumoclusters. These clusters will be characterized by clinical features, microbiology, and radiology, and compared for 30-day outcomes including mortality, ventilator-free days, antibiotic-free days, ICU-free days, and hospital-free days. Differential protein abundance analysis will be used to identify candidate biomarkers for pragmatic cluster assignment.
Data will be collected in electronic case report forms hosted in REDCap, with built-in quality checks. All data will be pseudonymized, and biological samples will be stored under controlled conditions for up to ten years for confirmatory analyses. No experimental interventions are administered; all patients receive standard care. The study has been approved by the Swedish Ethical Review Authority (Dnr 2025-04564-01) and equivalent bodies in participating countries. Results will be disseminated through peer-reviewed publications and scientific conferences, with statistical code shared for transparency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected ventilator-associated pneumonia | – | –Adult ICU patients receiving mechanical ventilation who undergo bronchoalveolar lavage (BAL) or mini-BAL for clinical suspicion of lower respiratory tract infection. Residual BAL fluid will be analyzed using proteomic profiling to identify biological subgroups ("pneumoclusters"). No experimental intervention is administered; all patients receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) admitted to intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom who are receiving invasive mechanical ventilation and undergo bronchoalveolar lavage (BAL) or mini-BAL for clinical suspicion of lower respiratory tract infection. Patients are enrolled at the time of sampling and followed for 30-day outcomes. No experimental interventions are administered; all patients receive standard care.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) admitted to an intensive care unit (ICU). Receiving invasive mechanical ventilation. Undergoing bronchoalveolar lavage (BAL) or mini-BAL on clinical indication for suspected lower respiratory tract infection.
- New or worsening clinical signs compatible with lower respiratory tract infection within the preceding 24 hours, defined as the treating clinician's suspicion plus at least one of:
- Body temperature >38 °C or <36 °C. Visually purulent tracheal secretions. Signs of reduced oxygenation (e.g., increased FiO₂ and/or decreased arterial pO₂, increased positive end-expiratory pressure or driving pressure).
- Request for chest radiograph to investigate infection or new infiltrate. Initiation of antibiotic therapy targeting lower respiratory tract infection.
Key exclusion criteria (2 listed)
- BAL or mini-BAL performed solely for screening without suspicion of infection. Concurrent enrolment in the VAPmarkers study (reserved for external validation).
- Age <18 years. Any condition that, in the opinion of the investigator, would preclude safe participation or confound study objectives.
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
Distribution of patients into biologically distinct clusters ("pneumoclusters") based on BAL proteomic data
Time frame: Day 0 (at enrolment)
Unsupervised consensus clustering of bronchoalveolar lavage (BAL) proteomic profiles, alone and in combination with clinical and microbiological variables, will be performed to classify patients with suspected ventilator-associated pneumonia into biologically distinct clusters ("pneumoclusters"). The number of clusters, the number of patients per cluster, and key distinguishing features will be reported.
5 secondary outcomes
30-day all-cause mortality
Time frame: 30 days after enrolment
Ventilator-free days
Time frame: 30 days after enrolment
Antibiotic-free days
Time frame: 30 days after enrolment
ICU-free days
Time frame: 30 days after enrolment
Hospital-free days
Time frame: 30 days after enrolment
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 30 Jun 2026.
- Derived from this study: PubMed 41802817Sjovall F, Povoa P, Petersson J, Koulenti D, Hernandez Padilla AC, Vaidie J, Lind A, Boetius Hertz F, Paulsson M. ClusterVAP: study protocol for multicentre proteomic endotyping of ventilator-associated pneumonia. BMJ Open Respir Res. 2026 Mar 9;13(1):e003830. doi: 10.1136/bmjresp-2025-003830.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results will be made available upon reasonable request to the corresponding author, subject to approval by relevant ethics committees and execution of appropriate data transfer agreements. Statistical code will be shared alongside the main publication. No genetic data will be shared.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Acquired Pneumonia and Mechanical Ventilation Complication, run by Region Skane at 4 sites in 3 countries.
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 2 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, France, Portugal. 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 Magnus Paulsson, MD PhD (+46703124424, magnus.paulsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of patients into biologically distinct clusters ("pneumoclusters") based on BAL proteomic data (time frame: Day 0 (at enrolment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07245888, which also lists 1 linked publication.
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 30 Jun 2026.