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NCT05117125 Clinical Trial

Biomarkers for Ventilator-associated Pneumonia

Pneumonia, Ventilator-Associated Clinical Trial

— VAPmarkers  

Official title:
Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05117125
Other study ID # 2021-00219
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date December 31, 2026

Study information
Verified date August 2023
Source Region Skane
Contact Magnus Paulsson, PhD MD
Phone +46461775431
Email magnus.paulsson@med.lu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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%

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Heparin-binding protein
Evaluation of the specificity and sensitivity of HBP as diagnostic biomarker for VAP.
• Interleukin-26
Evaluation of the specificity and sensitivity of IL-26 as diagnostic biomarker for VAP.
• Microbiome
Evaluation of the specificity and sensitivity of the lung microbiome as prognostic biomarker for VAP.
• Bacterial transcriptome
Evaluation of the specificity and sensitivity of the bacterial transcriptome as prognostic biomarker for treatment failure of VAP.
• Proteome
Evaluation of the specificity and sensitivity of the proteome in mini-BAL as biomarker for VAP.

Locations
Country Name City State
Sweden Skåne University Hospital, Dept. of Infectious diseases Lund
Sweden Skåne university Hospital, ICU Malmö
Sweden Karolinska University Hospital, ICU Solna

Sponsors (2)
Lead Sponsor Collaborator
Region Skane Lund University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Other Diagnostic certainty of VAP A scale from 0-100 of the diagnostic certainty by ICU physicians and nurses At VAP day 1
Other Change in CRP 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.
Other 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.
Other 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.
Other 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.
Other 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
Other 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.
Other 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.
Other 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.
Primary 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.
Primary 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.
Primary 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
Primary 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 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.
Secondary Bacterial transcriptome patterns Patterns in the bacterial gene expression that predict antibiotic drug treatment failure. VAP day 1
See also
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Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT00521677 - Comparison Between Two Methods of Oral Care on the Incidence of VAP N/A
Completed NCT00529776 - Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy N/A
Completed NCT03401463 - Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar N/A
Completed NCT02950519 - Endotracheal Tube Cuff Pressures in Ventilated Patients N/A
Completed NCT01875692 - Can we Better Understand the Development of VAP and Eventually Predict and Prevent it? N/A
Completed NCT00515034 - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia Phase 2
Completed NCT04755972 - Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2 N/A
Terminated NCT02940626 - Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus. Phase 2
Completed NCT01577862 - Colistin and Rifampicin for MDR-Acinetobacter Phase 3
Completed NCT00572559 - Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus Phase 4
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Recruiting NCT04215692 - Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients N/A
Completed NCT03816956 - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 Phase 3
Active, not recruiting NCT01123681 - Intubation and Extubation Over 48 Hours Mechanical Ventilation N/A
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Recruiting NCT03527992 - Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia N/A
Recruiting NCT05405491 - Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation N/A