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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAP | Enrolled participants that fully meet the criteria of 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. |
| |
| No VAP | Enrolled participants that do not develop VAP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin-binding protein | Diagnostic Test | Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic certainty of VAP | A scale from 0-100 of the diagnostic certainty by ICU physicians and nurses | At VAP day 1 |
| Change in CRP concentration | Compare cases with VAP to No VAP |
Inclusion Criteria:
Exclusion Criteria:
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General intensive care unit population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magnus Paulsson, PhD MD | Contact | +46461775431 | magnus.paulsson@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Magnus Paulsson, PhD MD | Skane University Hospital | Principal Investigator |
| Fredrik Sjövall, PhD MD | Skane University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken | Recruiting | Drammen | 3004 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37234157 | Background | Paulsson M, Cardenas EI, Che KF, Brundin B, Smith M, Qvarfordt I, Linden A. TLR4-mediated release of heparin-binding protein in human airways: a co-stimulatory role for IL-26. Front Immunol. 2023 May 10;14:1178135. doi: 10.3389/fimmu.2023.1178135. eCollection 2023. | |
| 34103069 | Background | Paulsson M, Thelaus L, Riesbeck K, Qvarfordt I, Smith ME, Linden A, Linder A. Heparin-binding protein in lower airway samples as a biomarker for pneumonia. Respir Res. 2021 Jun 8;22(1):174. doi: 10.1186/s12931-021-01764-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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Individual participant data that underlie the results reported in published articles will be shared with investigators after deidentification upon request.
IPD will be available from 6 months to 5 years after publication.
Approval of the relevant ethical board is necessary for access
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D064307 | Microbiota |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
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Mini-BAL Plasma Protected specimen brushes
|
| Interleukin-26 | Diagnostic Test | Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP. |
|
|
| 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. |
|
Patterns in the bacterial gene expression that predict antibiotic drug treatment failure.
| VAP day 1 |
| Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Change in Differential blood cell counts | Compare cases with VAP to No VAP | Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Change in PCT concentration | Compare cases with VAP to No VAP | Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Change in lactate concentration | Compare cases with VAP to No VAP | Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Routine bacterial culture results | Results from cultures at the clinical microbiology laboratory. Results will be correlated to bacterial species identification in mini-BAL. | When mini-BAL is collected |
| Change in Acute Physiology And Chronic Health Evaluation II (APACHE II) | Compare score between cases with VAP and no VAP. | Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Change in Sequential Organ Failure Assessment (SOFA) | Compare score between cases with VAP and no VAP. | Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Change in Simplified Acute Physiology Score III (Saps3) | Compare score between cases with VAP and no VAP. | Day 1, 3 and in selected patients day 7 and 14. In patients with VAP also VAP day 1, 3 and 7. |
| Hospital de São Francisco Xavier | Recruiting | Lisbon | Portugal |
|
| Skåne University Hospital, Dept. of Infectious diseases | Recruiting | Lund | Sweden |
|
| Skåne university Hospital, ICU | Recruiting | Malmö | Sweden |
|
| Karolinska University Hospital, ICU | Not yet recruiting | Solna | Sweden |
|
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |