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NCT Number: NCT05117125

Biomarkers for Ventilator-associated Pneumonia

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.

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Key information

Conditions

Pneumonia, Ventilator-Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestre Viken, Drammen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin-binding protein

Diagnostic Test

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

Other names: HBP

Interleukin-26

Diagnostic Test

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

Other names: IL-26

Microbiome

Diagnostic Test

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

Bacterial transcriptome

Diagnostic Test

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

Proteome

Diagnostic Test

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

Primary outcomes

  1. Change in HBP concentration over time

    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 concentration (ng/ml) compared to baseline.

  2. Change in IL-26 over time

    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 concentration (ng/ml) compared to baseline.

  3. HBP at VAP diagnosis

    Time frame: 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.

  4. IL-26 at VAP diagnosis

    Time frame: 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 outcomes

  1. Diversity of microbiome

    Time frame: 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.

  2. Bacterial transcriptome patterns

    Time frame: VAP day 1

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

Other outcomes

  1. Diagnostic certainty of VAP

    Time frame: At VAP day 1

    A scale from 0-100 of the diagnostic certainty by ICU physicians and nurses

  2. Change in CRP concentration

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

    Compare cases with VAP to No VAP

  3. Change in Differential blood cell counts

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

    Compare cases with VAP to No VAP

  4. Change in PCT concentration

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

    Compare cases with VAP to No VAP

  5. Change in lactate concentration

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

    Compare cases with VAP to No VAP

  6. Routine bacterial culture results

    Time frame: When mini-BAL is collected

    Results from cultures at the clinical microbiology laboratory. Results will be correlated to bacterial species identification in mini-BAL.

  7. Change in Acute Physiology And Chronic Health Evaluation II (APACHE II)

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

    Compare score between cases with VAP and no VAP.

  8. Change in Sequential Organ Failure Assessment (SOFA)

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

    Compare score between cases with VAP and no VAP.

  9. Change in Simplified Acute Physiology Score III (Saps3)

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

    Compare score between cases with VAP and no VAP.

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus Paulsson, PhD MD

CONTACT

[email protected]

+46461775431

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia

Acronym: VAPmarkers

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Nov 11, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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