Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 11:36 PM
Study NCT ID:
NCT01379066
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tuberculosis Volatile Organic Compounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-22', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of tuberculosis from bacterial plates', 'timeFrame': '6 months', 'description': 'Tuberculosis will be identified form culture plates by the volatile organic compound signature'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mycobacterium tuberculosis', 'Pulmonary tuberculosis', 'Electronic nose', 'Gas chromatography'], 'conditions': ['Pulmonary Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. It consists of:\n\n* A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air.\n* Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography.\n* Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection.\n* Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography.\n\nThis study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. This study will test the hypotheses:\n\n* that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification\n* that the investigators can identify control of tuberculosis by sampling exhaled breath'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard, Ca.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected tuberculosis infection or disease\n* Positive tuberculosis skin test\n* Positive sputum culture for TB\n* X-rays indicated possible tuberculosis infection or disease\n* ability to give breath and sputum samples at regular intervals\n\nExclusion Criteria:\n\n* Heavy smoker\n* History of or active pulmonary disease other than tuberculosis'}, 'identificationModule': {'nctId': 'NCT01379066', 'acronym': 'TBVOC', 'briefTitle': 'Tuberculosis Volatile Organic Compounds', 'organization': {'class': 'OTHER', 'fullName': 'Landon Pediatric Foundation'}, 'officialTitle': 'Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph', 'orgStudyIdInfo': {'id': 'TB1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tuberculosis Patients', 'description': 'Suspected Tuberculosis patients'}, {'label': 'Control', 'description': 'Healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93033', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Oxnard Specialty Clinic', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Pediatric Diagnostic Center', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Landon Pediatric Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}