- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379066
Tuberculosis Volatile Organic Compounds (TBVOC)
Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Oxnard, California, United States, 93033
- Oxnard Specialty Clinic
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Ventura, California, United States, 93003
- Pediatric Diagnostic Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspected tuberculosis infection or disease
- Positive tuberculosis skin test
- Positive sputum culture for TB
- X-rays indicated possible tuberculosis infection or disease
- ability to give breath and sputum samples at regular intervals
Exclusion Criteria:
- Heavy smoker
- History of or active pulmonary disease other than tuberculosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control
Healthy volunteers
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Tuberculosis Patients
Suspected Tuberculosis patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of tuberculosis from bacterial plates
Time Frame: 6 months
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Tuberculosis will be identified form culture plates by the volatile organic compound signature
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TB1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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