Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-19 @ 8:09 PM
Study NCT ID:
NCT03053258
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2017-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Exhaled breath saved for re-test in thirty days'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Breath Analysis', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': "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.\n\nPrimary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System in the early detection of VOC's associated with VAP.", 'detailedDescription': "On clinical suspicion of VAP, breath samples will be collected from the expiratory limb of the patient's ventilator tubing circuit. A sterile Tedlar collection bag will be used to connect to the sample port and collect the breath sample. The expiratory limb sample port will be utilized to ensure maintenance of the integrity of the ventilator circuitry. The breath samples will be analyzed via the ZNose breath analysis system.\n\nImmediately following collection of breath samples, bronchoalveolar lavage fluid (BALF) will be collected and subjected to bacteriology testing for confirmation of VAP-positive and VAP-negative patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients with suspected VAP infection', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:\n\n 1. Three or more positive out of the following:\n\n 1. Tympanic temperature \\> 38 °C or \\< 35.5 °C\n 2. Blood leukocytosis (10,000/µl)\n 3. More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field)\n 4. Positive culture of tracheal aspirate\n 2. New, persistent, or progressive infiltrate on chest radiograph\n\nExclusion Criteria:\n\nPatients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (\\< 40,000/µL) and other coagulation abnormalities.'}, 'identificationModule': {'nctId': 'NCT03053258', 'acronym': 'VAP-VOC', 'briefTitle': 'Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)', 'organization': {'class': 'OTHER', 'fullName': 'Landon Pediatric Foundation'}, 'officialTitle': 'Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Ventilator Acquired Pneumonia (VAP)', 'orgStudyIdInfo': {'id': 'Study 177 ZNose'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic Breath Analysis: VAP', 'description': 'Collection of exhaled breath samples', 'interventionNames': ['Device: Collection of exhaled breath sample']}], 'interventions': [{'name': 'Collection of exhaled breath sample', 'type': 'DEVICE', 'description': 'Collect exhaled breath sample from patients with suspected VAP', 'armGroupLabels': ['Diagnostic Breath Analysis: VAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Medical Center', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Chris Landon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ventura County Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Landon Pediatric Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}