Biomarkers for Ventilator-associated Pneumonia

Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05117125

Acronym

VAPmarkers

Enrollment

1000

Registered

2021-11-11

Start date

2021-10-15

Completion date

2028-12-31

Last updated

2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Ventilator-Associated

Keywords

VAP

Brief summary

The purpose of this study is to evaluate different peptide biomarkers, variations in the microbiome and patterns in the bacterial transcriptome as prognostic or diagnostic biomarkers of VAP.

Interventions

DIAGNOSTIC_TESTHeparin-binding protein

Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.

DIAGNOSTIC_TESTInterleukin-26

Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.

DIAGNOSTIC_TESTMicrobiome

Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.

DIAGNOSTIC_TESTBacterial transcriptome

Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.

DIAGNOSTIC_TESTProteome

Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Admission to an intensive care unit * Intubation within last 24 hours * Anticipated mechanical ventilation of at least 48 hours

Exclusion criteria

* FiO2 above 70% or PEEP above 15 * Severe coagulopathy (spontaneous PK(INR) \>1.8 or thrombocytes \<50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors/NOAC is not an

Design outcomes

Primary

Measure	Time frame	Description
Change in HBP concentration over time	Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.	Change in concentration (ng/ml) compared to baseline.
Change in IL-26 over time	Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.	Change in concentration (ng/ml) compared to baseline.
HBP at VAP diagnosis	VAP day 1 compared to No VAP day 3	Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.
IL-26 at VAP diagnosis	VAP day 1 compared to No VAP day 3	Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.

Secondary

Measure	Time frame	Description
Diversity of microbiome	Day 1 and 3, and VAP day 1.	Changes in alpha and beta diversity as prognostic biomarker for VAP. Cases that develop VAP are compared to cases with no VAP.
Bacterial transcriptome patterns	VAP day 1	Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.

Countries

Norway, Portugal, Sweden

Contacts

CONTACTMagnus Paulsson, PhD MD

magnus.paulsson@med.lu.se+46461775431

PRINCIPAL_INVESTIGATORMagnus Paulsson, PhD MD

Skane University Hospital

STUDY_CHAIRFredrik Sjövall, PhD MD