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Endotyping of Ventilator-associated Pneumonia With Proteomics on Bronchoalveolar Lavage for Improved Diagnosis, the ClusterVAP Study

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Limoges
NOT_YET_RECRUITING
Limoges
Portugal
Hospital de São Francisco Xavier
NOT_YET_RECRUITING
Lisbon
Sweden
Skånes universitetssjukhus
RECRUITING
Lund
Karolinska universitetssjukhuset
RECRUITING
Stockholm
Contact Information
Primary
Magnus Paulsson, MD PhD
magnus.paulsson@med.lu.se
+46703124424
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 400
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: King's College Hospital NHS Trust, Umeå University, Karolinska University Hospital, Lund University, NOVA Medical School, University Hospital, Limoges, Rigshospitalet, Denmark
Leads: Region Skane

This content was sourced from clinicaltrials.gov

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