ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-Associated Pneumonia
Official title: Endotyping of Ventilator-associated Pneumonia With Proteomics on Bronchoalveolar Lavage for Improved Diagnosis, the ClusterVAP Study
Run by Region Skane · NCT07245888 · Data updated 2026-11-12
Researchers will test whether proteomic patterns in BAL fluid can identify subgroups of patients with suspected VAP on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 4 sites (Limoges and 3 other locations) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07245888 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult ICU patients on invasive mechanical ventilation undergoing BAL or mini-BAL for suspected lower respiratory tract infection.
✕Probably not a fit
Patients whose BAL proteomic profiles do not define a clinically useful pneumocluster or who do not experience outcomes influenced by clustering may not see direct benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ClusterVAP is an observational study across multiple ICUs in Europe that analyzes proteins in bronchoalveolar lavage samples from adults on invasive ventilation to find distinct patient subgroups. Using LC-MS/MS proteomics and unsupervised clustering, the study aims to define pneumoclusters by integrating proteomic data with clinical and microbiological information. The goal is to link these clusters with clinical outcomes such as mortality and days free from ventilation or ICU care, and to identify candidate biomarkers for future diagnostics. Data are collected in REDCap with pseudonymization, and samples are stored for up to ten years for confirmatory analyses. No experimental treatment is given; all care remains standard.
Why it matters
Potential benefit: If successful, the study could improve understanding of VAP subtypes and inform more precise diagnostics and future biomarker-guided approaches.
How similar studies have gone: Previous studies in proteomics and pneumonia have shown potential for endotyping, but this approach in VAP is exploratory and novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Where it's running
-
Skånes universitetssjukhus
Lund, Sweden Recruiting -
Karolinska universitetssjukhuset
Stockholm, Sweden Recruiting -
CHU Limoges
Limoges, France Not yet recruiting -
Hospital de São Francisco Xavier
Lisbon, Portugal Not yet recruiting
Study contacts
- Study coordinator: Magnus Paulsson, MD PhD
- Email: magnus.paulsson@med.lu.se
- Phone: +46703124424
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.