Biomarkers for Ventilator-associated Pneumonia

Region Skane1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Pneumonia, Ventilator-Associated

Interventions

Heparin-binding proteinDIAGNOSTIC_TEST

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

Interleukin-26DIAGNOSTIC_TEST

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

MicrobiomeDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Vestre Viken

Drammen, Norway

RECRUITING

Hospital de São Francisco Xavier

Lisbon, Portugal

RECRUITING

Skåne University Hospital, Dept. of Infectious diseases

Lund, Sweden

RECRUITING

Outcomes

Primary Outcomes

Change in HBP concentration over time

Change in concentration (ng/ml) compared to baseline.

Time frame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.

Change in IL-26 over time

Change in concentration (ng/ml) compared to baseline.

Time frame: Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.

HBP at VAP diagnosis

Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.

Time frame: VAP day 1 compared to No VAP day 3

IL-26 at VAP diagnosis

Concentration at VAP day 1, compared to day 3 in patients with no VAP. ROC curves, specificity and sensitivity as diagnostic biomarker.

Time frame: VAP day 1 compared to No VAP day 3

Secondary Outcomes

Diversity of microbiome

Changes in alpha and beta diversity as prognostic biomarker for VAP. Cases that develop VAP are compared to cases with no VAP.

Time frame: Day 1 and 3, and VAP day 1.

Bacterial transcriptome patterns

Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.

Time frame: VAP day 1

Central Contacts

Magnus Paulsson, PhD MD

CONTACT

+46461775431 magnus.paulsson@med.lu.se

Data from ClinicalTrials.gov

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