ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-associated Pneumonia

NCT07245888 | Not Yet Recruiting

• 1 other identifier: 2025-04564-01
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Ventilator Acquired Pneumonia; Mechanical Ventilation Complication

Keywords

VAP; endotyping; mini-BAL

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 (at enrolment)

Secondary Outcomes (5)

• 30-day all-cause mortality

  30 days after enrolment

• Ventilator-free days

  30 days after enrolment

• Antibiotic-free days

  30 days after enrolment

• ICU-free days

  30 days after enrolment

• Hospital-free days

  30 days after enrolment

Other Outcomes (1)

• Identification of candidate protein biomarkers for cluster assignment

  Day 0 (at enrolment)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• NOVA Medical School: collaborator
• Rigshospitalet, Denmark: collaborator
• Karolinska University Hospital: collaborator
• University Hospital, Limoges: collaborator
• King's College Hospital NHS Trust: collaborator
• Umeå University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Magnus Paulsson, MD PhD

CONTACT

+46703124424; magnus.paulsson@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be available after publication of the main results and will remain available for up to 10 years after study completion or until the destruction of biological samples, whichever occurs first.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or healthcare institutions who submit a methodologically sound proposal. Requests should be directed to the corresponding author and will require approval by the study steering committee and relevant ethics committees.