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Tuberculosis Volatile Organic Compounds (TBVOC)

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ClinicalTrials.gov Identifier: NCT01379066
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Landon Pediatric Foundation

Brief Summary:

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
Pulmonary Tuberculosis

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort
Tuberculosis Patients
Suspected Tuberculosis patients
Control
Healthy volunteers



Primary Outcome Measures :
  1. Identification of tuberculosis from bacterial plates [ Time Frame: 6 months ]
    Tuberculosis will be identified form culture plates by the volatile organic compound signature



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard, Ca.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Oxnard Specialty Clinic
Oxnard, California, United States, 93033
Pediatric Diagnostic Center
Ventura, California, United States, 93003
Sponsors and Collaborators
Landon Pediatric Foundation

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Responsible Party: Landon Pediatric Foundation
ClinicalTrials.gov Identifier: NCT01379066     History of Changes
Other Study ID Numbers: TB1
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by Landon Pediatric Foundation:
Mycobacterium tuberculosis
Pulmonary tuberculosis
Electronic nose
Gas chromatography

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections