Pneumonia, Ventilator-associatedcheqVAPNCT02753608
Early Detection of Ventilator-associated Pneumonia (VAP)
A study testing Collection of exhaled breath condensate in people with Pneumonia, Ventilator-associated, run by Jena University Hospital at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-associated
- What is being tested?
- Collection of exhaled breath condensate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients on invasive ventilation
- Signed informed consent
Who cannot join
- Glucocorticoid dosage above 0.3 mg/kg Prednisolone equivalent over more than 3 weeks
- Treatment with recognized T cell immunosuppressant (cyclosporine, Tumor Necrosis Factor antagonists) or nucleoside analogues during the preceding 90 days
- Inherited severe immunodeficiency
- Solid organ or stem cell transplant recipients
- Anti-cancer chemotherapy during the preceding 90 days
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Pneumonia, Ventilator-associated
- Being tested
- Collection of exhaled breath condensate
- Keywords
- exhaled breath condensate, volatile organic compounds
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of exhaled breath condensateOther
Also called EBC collection
An sampling device (authorized for this use) will be connected to the expiratory line of the ventilator. Exhaled breath condensates accumulate in a cooled container.
| Study group | Role | What they receive |
|---|---|---|
| No ventilator-associated pneumonia (VAP) | Sham comparator | Collection of exhaled breath condensate (EBC) in patients without clinical signs of VAP Receives: Other: Collection of exhaled breath condensate |
| Ventilator-associated pneumonia (VAP) | Experimental | Collection of exhaled breath condensate (EBC) in patients displaying clinical signs of VAP Receives: Other: Collection of exhaled breath condensate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP
Raman spectrum of volatile organic compounds
Measured: 24 hours upon clinical diagnosis confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start28 Jun 2016
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-associatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Pletz, Jena University Hospital
- Investigators
- Mathias Pletz, MD, Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753608
- Sponsor's protocol ID
- ZKSJ0093
- Acronym
- cheqVAP
- Status last verified
- Jul 2018
- First submitted
- 31 Mar 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will be not made available
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhalate Sample Collection for Raman Spectroscopy-based Early Detection of Ventilator-associated Pneumonia (VAP)
- ClinicalTrials.gov ID
- NCT02753608
- Acronym / sponsor ID
- cheqVAP / ZKSJ0093
- Conditions
- Pneumonia, Ventilator-associated
- Keywords
- exhaled breath condensate, volatile organic compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No ventilator-associated pneumonia (VAP) | Sham comparator | Other: Collection of exhaled breath condensateCollection of exhaled breath condensate (EBC) in patients without clinical signs of VAP |
| Ventilator-associated pneumonia (VAP) | Experimental | Other: Collection of exhaled breath condensateCollection of exhaled breath condensate (EBC) in patients displaying clinical signs of VAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICU patients on invasive ventilation
- Signed informed consent
Key exclusion criteria (5 listed)
- Glucocorticoid dosage above 0.3 mg/kg Prednisolone equivalent over more than 3 weeks
- Treatment with recognized T cell immunosuppressant (cyclosporine, Tumor Necrosis Factor antagonists) or nucleoside analogues during the preceding 90 days
- Inherited severe immunodeficiency
- Solid organ or stem cell transplant recipients
- Anti-cancer chemotherapy during the preceding 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of exhaled breath condensateAlso: EBC collectionAn sampling device (authorized for this use) will be connected to the expiratory line of the ventilator. Exhaled breath condensates accumulate in a cooled container. | Other | No ventilator-associated pneumonia (VAP), Ventilator-associated pneumonia (VAP) |
Primary outcome
Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP
Time frame: 24 hours upon clinical diagnosis confirmation
Raman spectrum of volatile organic compounds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: No. Individual participant data will be not made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Pletz, MD principal investigator
Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of exhaled breath condensate in people with Pneumonia, Ventilator-associated, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP (time frame: 24 hours upon clinical diagnosis confirmation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.