Tuberculosis Volatile Organic Compounds

Completed

• Conditions: Pulmonary Tuberculosis

• Registration Number: NCT01379066
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Pediatric Diagnostic Center; 🇺🇸 Ventura, California, United States

Oxnard Specialty Clinic; 🇺🇸 Oxnard, California, United States