Tuberculosis Volatile Organic Compounds

Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01379066

Acronym

TBVOC

Enrollment

Registered

2011-06-23

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Tuberculosis

Keywords

Mycobacterium tuberculosis, Pulmonary tuberculosis, Electronic nose, Gas chromatography

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results