Clinical trial Recruiting at 2 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorRegion Skane
Academic / other
Locations4 sites (Limoges and 3 other locations)
StatusRecruiting
StartedMay 1, 2026
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedJune 30, 2026
Trial IDNCT07245888 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.