search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number25468
- NTR NumberNTR6114
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2016
- Secondary IDsUKCRN ID 19086
- Public TitleBreathDx – Molecular Analysis of Exhaled Breath as a Diagnostic Test for Ventilator–Associated Pneumonia
- Scientific TitleBreathDx – Molecular Analysis of Exhaled Breath as a Diagnostic Test for Ventilator–Associated Pneumonia
- ACRONYMBreathDx
- hypothesis1) Molecular analysis of breath can be used to discriminate between patients that are suspected of ventilator-associated pneumonia (VAP) who have positive cultures and who have negative cultures with high sensitivity (which could limit antibiotic use).
2) Molecular analysis of breath can be used to specifically detect the causative pathogen in patients that are suspected of VAP (so that antibiotics can be targeted).
- Healt Condition(s) or Problem(s) studiedPneumonia, Ventilator associated lung injury
- Inclusion criteria1. 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 criteria1. 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)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jun-2015
- planned closingdate1-jun-2017
- Target number of participants153
- InterventionsThis 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 definition of VAP) and clinically suspected of having VAP. Exhaled air samples will be taken within 24 hours after the patient is suspected of VAP. Broncho-alveolar lavage fluid will be collected to clinically determine the presence of VAP.
- Primary outcomeCombination 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 outcome1) 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.
- TimepointsOnly 1 time point: all samples are taken at time of recruitment.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Tamara Nijssen
- CONTACT for SCIENTIFIC QUERIESDr. Tamara Nijssen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, University Hospital South Manchester NHS Foundation Trust
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryIntensive Care Units (ICUs) treat and monitor critically ill or unstable patients who may be unable to breathe on their own and whose organs may not be working properly. Medical equipment supports organ function until the patient recovers. Mechanical ventilators (‘life support machines’) support breathing. While this technology works well, patients on mechanical ventilators can develop life-threatening lung infections (pneumonia) as a complication. Pneumonia is treated quickly and effectively with antibiotic drugs. However, because patients on ventilators are already ill, it is not possible to diagnose pneumonia quickly and accurately. Therefore many mechanically ventilated patients will also receive antibiotic treatments ‘just in case’ which means that antibiotics will be used unnecessarily. A consequence of antibiotic overuse is that infecting bugs (microorganisms) become resistant so that it will be difficult to treat life- threatening pneumonia in the future. We need to develop new technologies to help decide quickly who has developed pneumonia during their time on mechanical ventilation. Recently, we have discovered that it is possible and safe to capture and measure breath chemicals of patients who are mechanically ventilated. The chemical profiles appear to distinguish patients acquiring dangerous lung microorganisms. This exciting finding implies that we could use these chemical patterns to determine quickly who is likely to require antibiotics and who does not. To progress this idea, we now wish to use our breath capture system in ICU ventilated patients suspected of developing pneumonia and, using analysis already developed in our laboratories, we will seek proof that these chemicals can distinguish between the presence and absence of pneumonia. At project completion we will be able to decide whether our innovation is ready for clinical testing across ICUs in Europe.
- Main changes (audit trail)
- RECORD28-okt-2016 - 11-dec-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl