Pneumonia, Ventilator-associated Clinical Trial
Official title:
Exhalate Sample Collection for Raman Spectroscopy-based Early Detection of Ventilator-associated Pneumonia (VAP)
The study goal consists in the sequential collection of exhaled breath condensates (EBC) from patients receiving invasive ventilation. Subsequent Raman spectroscopy aims at the identification of putative biomarkers that could enable rapid early distinction of Ventilator-associated pneumonia.
Diagnostics of VAP relies on two complementary strategies: meeting pre-defined clinical
criteria and evidence of pathogens in the lower respiratory tract. Mere reliance on clinical
symptoms, such as radiologic evidence, systemic signs of inflammation and indices of
compromised pulmonary function reportedly lead to misdiagnosis. Current diagnostic procedures
recommend gathering of evidence for new or progressive lung infiltrates from serial chest
radiographies, together with co-existing clinical signs of impaired respiratory function.
Microbiological confirmation of pathogen presence requires examination of airway secretions
collected by invasive bronchoalveolar lavage which demands specific technical skills and
staff training. Although verification of causal pathogens is essential for the introduction
of targeted antibiotic therapy, the procedure is time-consuming and qualitative in reportedly
less than 30 % of the cases. Furthermore, the currently adopted diagnostic approaches are
based on sporadic information sampling and do not support continuous monitoring and
evaluation of the effect of therapeutic interventions. All above-listed flaws and
shortcomings emphasize the need for rapid, reliable and non-invasive recognition of VAP,
preferably in a setting that would permit continuous bedside monitoring and timely
introduction of targeted drug therapy.
The study objective consists in sequential collection of exhaled breath condensates (EBC) in
ICU patients receiving invasive ventilation. The EBC samples will be subjected to
determination of volatile organic compound (VOC) profiles by Stimulated Raman Spectroscopy
(SRS) which, upon individual matching to routinely collected clinical parameters, may become
putative biomarkers for the early recognition of VAP. Evidence has accumulated in support of
the assumption that certain metabolites in EBC might display significant profile differences
as to their size, hydrophobicity and electrical charge. Identification of VAP-specific
profiles of VOC will provide the basis for the generation of a data base enabling the
construction and standardization of a bedside device for continuous real-time point-of-care
monitoring of VAP hazard in patients on invasive ventilation.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02806141 -
Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates
|
Phase 3 | |
| 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 | |
| Recruiting |
NCT05117125 -
Biomarkers for Ventilator-associated Pneumonia
|
||
| 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 | |
| Not yet recruiting |
NCT04566172 -
Preoperative Optimization to Improve Functional Status
|
N/A | |
| 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 | |
| Recruiting |
NCT04839653 -
Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria
|
N/A | |
| 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 |