Tuberculosis Volatile Organic Compounds (TBVOC)

August 12, 2014 updated by: Landon Pediatric Foundation

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

Completed

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Oxnard, California, United States, 93033
        • Oxnard Specialty Clinic
      • Ventura, California, United States, 93003
        • Pediatric Diagnostic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard, Ca.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy volunteers
Tuberculosis Patients
Suspected Tuberculosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of tuberculosis from bacterial plates
Time Frame: 6 months
Tuberculosis will be identified form culture plates by the volatile organic compound signature
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (ESTIMATE)

June 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

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.

Clinical Trials on Pulmonary Tuberculosis

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