VAPmarkers: Biomarkers for Ventilator-associated Pneumonia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| VAP Enrolled participants that fully meet the criteria of VAP. |
Diagnostic Test: Heparin-binding protein
Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
Other Names:
Diagnostic Test: Interleukin-26
Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
Other Names:
Diagnostic Test: Microbiome
Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
Diagnostic Test: Bacterial transcriptome
Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.
Diagnostic Test: Proteome
Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.
|
| Suspect VAP Enrolled participants that develop signs of VAP but lack some variable, for instace new radiographic infiltrate or microbiological finding compatible with VAP. |
Diagnostic Test: Heparin-binding protein
Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
Other Names:
Diagnostic Test: Interleukin-26
Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
Other Names:
Diagnostic Test: Microbiome
Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
Diagnostic Test: Proteome
Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.
|
| No VAP Enrolled participants that do not develop VAP. |
Diagnostic Test: Heparin-binding protein
Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
Other Names:
Diagnostic Test: Interleukin-26
Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
Other Names:
Diagnostic Test: Microbiome
Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
Diagnostic Test: Proteome
Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.
|
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- 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.
- Bacterial transcriptome patterns [VAP day 1]
Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.
Other Outcome Measures
- Diagnostic certainty of VAP [At VAP day 1]
A scale from 0-100 of the diagnostic certainty by ICU physicians and nurses
- Change in CRP concentration [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
- Change in Differential blood cell counts [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
- Change in PCT concentration [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
- Change in lactate concentration [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
- Routine bacterial culture results [When mini-BAL is collected]
Results from cultures at the clinical microbiology laboratory. Results will be correlated to bacterial species identification in mini-BAL.
- Change in Acute Physiology And Chronic Health Evaluation II (APACHE II) [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.
- Change in Sequential Organ Failure Assessment (SOFA) [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.
- Change in Simplified Acute Physiology Score III (Saps3) [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.
Eligibility Criteria
Criteria
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 80%
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skåne University Hospital, Dept. of Infectious diseases | Lund | Sweden | ||
| 2 | Skåne university Hospital, ICU | Malmö | Sweden | ||
| 3 | Karolinska University Hospital, ICU | Solna | Sweden |
Sponsors and Collaborators
- Region Skane
- Lund University
Investigators
- Principal Investigator: Magnus Paulsson, PhD MD, Skane University Hospital
- Study Chair: Fredrik Sjövall, PhD MD, Skane University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-00219