Biomarkers for Ventilator-associated Pneumonia

NCT05117125 · tracked via the Priya Life Science Norway tracker

Sponsor

Region Skane

Phase

Observational

Started

2021-10-15

Last updated

2026-06-26

Condition(s) studied

Pneumonia, Ventilator-Associated

Investigational drug(s) / intervention(s)

Heparin-binding proteinInterleukin-26MicrobiomeBacterial transcriptomeProteome

Heparin-binding protein: Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.

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

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

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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 exclusion criteria. If higher doses of these substances are administered, the responsible clinician should be consulted before sample collection. * Ongoing infection of the lungs at admission to the ICU. * Severely elevated or instable intracranial pressure.

Primary outcome measure(s)

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.

Trial sites (5)

Facility	City	Region	Status
Vestre Viken	Drammen	Norway	Recruiting
Hospital de São Francisco Xavier	Lisbon	Portugal	Recruiting
Skåne University Hospital, Dept. of Infectious diseases	Lund	Sweden	Recruiting
Skåne university Hospital, ICU	Malmö	Sweden	Recruiting
Karolinska University Hospital, ICU	Solna	Sweden	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05117125 on ClinicalTrials.gov ↗ ← All trials in Norway