NCT07245888 ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-associated Pneumonia
| NCT ID | NCT07245888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Ventilator Acquired Pneumonia |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2026-05-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventilator Acquired Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07245888 currently recruiting?
Yes, NCT07245888 is actively recruiting participants. Contact the research team at magnus.paulsson@med.lu.se for enrollment information.
Where is the NCT07245888 trial being conducted?
This trial is being conducted at Limoges, France, Lisbon, Portugal, Lund, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT07245888 clinical trial?
NCT07245888 is sponsored by Region Skane. The trial plans to enroll 400 participants.