ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-associated Pneumonia

ConditionsVentilator Acquired Pneumonia Mechanical Ventilation Complication

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorRegion Skane

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants

are grouped into 1 trial group

Group A: Patients with suspected ventilator-associated pneumonia

Trial outcomes

Primary outcomes

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.

Time frame

Day 0 (at enrolment)

Secondary outcomes

30-day all-cause mortality

Mortality status compared across identified clusters.

Time frame

30 days after enrolment

Ventilator-free days

Number of days alive and free from invasive mechanical ventilation.

Time frame

30 days after enrolment

Antibiotic-free days

Number of days alive and not receiving systemic antibiotics.

Time frame

30 days after enrolment

ICU-free days

Number of days alive and not in an intensive care unit.

Time frame

30 days after enrolment

Other outcomes

Identification of candidate protein biomarkers for cluster assignment

Differential abundance analysis of bronchoalveolar lavage (BAL) proteomic data will be performed to identify candidate protein biomarkers that distinguish biologically defined patient clusters ("pneumoclusters"). The analysis will aim to derive a minimal set of proteins suitable for pragmatic cluster assignment in future cohorts. Results will include fold changes, statistical significance (e.g., adjusted p-values), and performance metrics (e.g., AUC) for each candidate biomarker.

Time frame

Day 0 (at enrolment)