Tuberculosis Volatile Organic Compounds (TBVOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01379066|
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : August 13, 2014
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:
- 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.
- Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography.
- Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection.
- Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography.
This 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:
- that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification
- that the investigators can identify control of tuberculosis by sampling exhaled breath
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
Suspected Tuberculosis patients
- Identification of tuberculosis from bacterial plates [ Time Frame: 6 months ]Tuberculosis will be identified form culture plates by the volatile organic compound signature
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379066
|United States, California|
|Oxnard Specialty Clinic|
|Oxnard, California, United States, 93033|
|Pediatric Diagnostic Center|
|Ventura, California, United States, 93003|