NCT03053258

Brief Summary

Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in previous animal models. Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System in the early detection of VOC's associated with VAP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

February 9, 2017

Last Update Submit

May 3, 2019

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Breath Analysis

    Diagnostic analysis of Volatile Organic Compounds in exhaled breath samples These are compared to known compounds associated with sepsis in exhaled breath in septic rats, such as the oliphenones.

    6 months

Study Arms (1)

Diagnostic Breath Analysis: VAP

Collection of exhaled breath samples

Device: Collection of exhaled breath sample

Interventions

Collection of exhaled breath sampleDEVICE

Collect exhaled breath sample from patients with suspected VAP

Diagnostic Breath Analysis: VAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mechanically ventilated patients with suspected VAP infection

You may qualify if:

  • Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:
  • Three or more positive out of the following:
  • Tympanic temperature \> 38 °C or \< 35.5 °C
  • Blood leukocytosis (10,000/µl)
  • More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field)
  • Positive culture of tracheal aspirate
  • New, persistent, or progressive infiltrate on chest radiograph

You may not qualify if:

  • Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (\< 40,000/µL) and other coagulation abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ventura County Medical Center

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath saved for re-test in thirty days

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Chris Landon, MD

    Ventura County Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 15, 2017

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

February 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)