Biomarkers for Ventilator-associated Pneumonia
VAPmarkers
Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia
1 other identifier
observational
1,000
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2021
CompletedStudy Start
First participant enrolled
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
November 15, 2024
November 1, 2024
5.2 years
October 15, 2021
November 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Diversity of microbiome
Day 1 and 3, and VAP day 1.
Bacterial transcriptome patterns
VAP day 1
Other Outcomes (9)
Diagnostic certainty of VAP
At VAP day 1
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.
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.
- +6 more other outcomes
Study Arms (3)
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.
Interventions
Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.
Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.
Eligibility Criteria
General intensive care unit population.
You may qualify if:
- Admission to an intensive care unit
- Intubation within last 24 hours
- Anticipated mechanical ventilation of at least 48 hours
You may not qualify if:
- FiO2 above 70% or PEEP above 15
- Ongoing infection of the lungs at admission to the ICU.
- Severely elevated or instable intracranial pressure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Lund Universitycollaborator
Study Sites (5)
Vestre Viken
Drammen, 3004, Norway
Hospital de São Francisco Xavier
Lisbon, Portugal
Skåne University Hospital, Dept. of Infectious diseases
Lund, Sweden
Skåne university Hospital, ICU
Malmo, Sweden
Karolinska University Hospital, ICU
Solna, Sweden
Related Publications (2)
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.
PMID: 37234157BACKGROUNDPaulsson 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.
PMID: 34103069BACKGROUND
Related Links
Biospecimen
Mini-BAL Plasma Protected specimen brushes
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Paulsson, PhD MD
Skane University Hospital
- STUDY CHAIR
Fredrik Sjövall, PhD MD
Skane University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
November 11, 2021
Study Start
October 15, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
November 15, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- IPD will be available from 6 months to 5 years after publication.
- Access Criteria
- Approval of the relevant ethical board is necessary for access
Individual participant data that underlie the results reported in published articles will be shared with investigators after deidentification upon request.