Biomarkers for Ventilator-associated Pneumonia
ConditionPneumonia, Ventilator-Associated
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Admission to an intensive care unit
Intubation within last 24 hours
Anticipated mechanical ventilation of at least 48 hours
Disqualifiers
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.
Trial population
General intensive care unit population.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Heparin-binding protein
Diagnostic testEvaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
Interleukin-26
Diagnostic testEvaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
Microbiome
Diagnostic testEvaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
Bacterial transcriptome
Diagnostic testEvaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.
Proteome
Diagnostic testEvaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: VAP5 interventions
Group B: Suspect VAP4 interventions
Group C: No VAP4 interventions
Trial outcomes
Primary outcomes
1
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 7.2
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 7.3
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 34
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 3Secondary outcomes
1
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 1.2
Bacterial transcriptome patterns
Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.
Time frame
VAP day 1Other outcomes
1
Diagnostic certainty of VAP
A scale from 0-100 of the diagnostic certainty by ICU physicians and nurses
Time frame
At VAP day 12
Change in CRP concentration
Compare cases with VAP to No VAP
Time frame
Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.3
Change in Differential blood cell counts
Compare cases with VAP to No VAP
Time frame
Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.4
Change in PCT concentration
Compare cases with VAP to No VAP
Time frame
Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Lund University
Collaborator
Source ClinicalTrials.gov