Biomarkers for Ventilator-associated Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia

Conditions
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Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Diagnostic Test: Heparin-binding protein
* Diagnostic Test: Interleukin-26
* Diagnostic Test: Microbiome
* Diagnostic Test: Bacterial transcriptome
* Diagnostic Test: Proteome


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VAP<br>Enrolled participants that fully meet the criteria of VAP. | Diagnostic Test: Heparin-binding protein<br>* Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.<br>* Other names: HBP;Diagnostic Test: Interleukin-26<br>* Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.<br>* Other names: IL-26;Diagnostic Test: Microbiome<br>* Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.<br>Diagnostic Test: Bacterial transcriptome<br>* Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.<br>Diagnostic Test: Proteome<br>* Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.<br>|
| Suspect VAP<br>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<br>* Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.<br>* Other names: HBP;Diagnostic Test: Interleukin-26<br>* Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.<br>* Other names: IL-26;Diagnostic Test: Microbiome<br>* Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.<br>Diagnostic Test: Proteome<br>* Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.<br>|
| No VAP<br>Enrolled participants that do not develop VAP. | Diagnostic Test: Heparin-binding protein<br>* Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.<br>* Other names: HBP;Diagnostic Test: Interleukin-26<br>* Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.<br>* Other names: IL-26;Diagnostic Test: Microbiome<br>* Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.<br>Diagnostic Test: Proteome<br>* Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HBP concentration over time | Change in concentration (ng/ml) compared to baseline. | 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. | 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. | 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. | VAP day 1 compared to No VAP day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 and 3, and VAP day 1. | 
| Bacterial transcriptome patterns | Patterns in the bacterial gene expression that predict antibiotic drug treatment failure. | VAP day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VAP