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BreathDx – Molecular Analysis of Exhaled Breath as a Diagnostic Test for Ventilator–Associated Pneumonia

BreathDx – Molecular Analysis of Exhaled Breath as a Diagnostic Test for Ventilator–Associated Pneumonia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20773
Enrollment
153
Registered
2016-10-28
Start date
2015-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breath analysis

Interventions

This is a diagnostic multicentre cross-sectional observational proof of concept study. Included patients will have been intubated and mechanically ventilated for at least 48 hours (based on the defini

Sponsors

Academic Medical Centre, Amsterdam, the Netherlands; and University Hospital South Manchester NHS Foundation Trust, United Kingdom
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years and older 2. Intubated and mechanically ventilated for >48 hours 3. Suspected for ventilator associated pneumonia (VAP) Definition of suspected VAP: start of antibiotics for a suspected lower respiratory infection in a patient that has been on mechanical ventilation for more than 48h

Exclusion criteria

Exclusion criteria: 1. Patients receiving end of life care 2. Patients where there is clinical suspicion of highly infectious disease (patients in strict isolation such as Middle East Respiratory Syndrome, Ebola or resistant tuberculosis)

Design outcomes

Primary

MeasureTime frame
Combination of volatile markers that gives an accurate discrimination between patients that are suspected of VAP who have positive cultures and who have negative cultures with a sensitivity of at least 99%.

Secondary

MeasureTime frame
1) Molecular markers that can distinguish between patients with and without microbiologically confirmed VAP with p <0.05 and a false discovery rate < 0.05. 2) Molecular markers that can distinguish between patients with and without specific pathogens with p <0.05 and a false discovery rate < 0.05. 3) Accuracy of discrimination within the subgroup of patients with and without a previous respiratory infection. 4) Accuracy of discrimination within the subgroup of patients intubated for less and more than one week.

Contacts

Public ContactTamara Nijssen

Philips Research

email: tamara.nijsen@philips.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)