Biomarkers for Ventilator-associated Pneumonia

Recruiting

• Conditions: Pneumonia, Ventilator-Associated
• Interventions: Diagnostic Test: Heparin-binding protein; Diagnostic Test: Interleukin-26; Diagnostic Test: Microbiome; Diagnostic Test: Proteome; Diagnostic Test: Bacterial transcriptome

• Registration Number: NCT05117125
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-31
• Study First Posted: 2021-11-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspect VAP	Interleukin-26	Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP.
Suspect VAP	Proteome	Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP.
No VAP	Microbiome	Enrolled participants that do not develop VAP.
No VAP	Proteome	Enrolled participants that do not develop VAP.
VAP	Bacterial transcriptome	Enrolled participants that fully meet the criteria of VAP.
VAP	Proteome	Enrolled participants that fully meet the criteria of VAP.
Suspect VAP	Heparin-binding protein	Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP.
VAP	Microbiome	Enrolled participants that fully meet the criteria of VAP.
Suspect VAP	Microbiome	Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP.
VAP	Heparin-binding protein	Enrolled participants that fully meet the criteria of VAP.
VAP	Interleukin-26	Enrolled participants that fully meet the criteria of VAP.
No VAP	Heparin-binding protein	Enrolled participants that do not develop VAP.
No VAP	Interleukin-26	Enrolled participants that do not develop VAP.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Bacterial transcriptome patterns	VAP day 1	Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.
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.

Trial Locations

Locations (5)

Vestre Viken; 🇳🇴 Drammen, Norway

Hospital de São Francisco Xavier; 🇵🇹 Lisbon, Portugal

Skåne University Hospital, Dept. of Infectious diseases; 🇸🇪 Lund, Sweden

Skåne university Hospital, ICU; 🇸🇪 Malmö, Sweden

Karolinska University Hospital, ICU; 🇸🇪 Solna, Sweden