Tuberculosis Volatile Organic Compounds

Pulmonary Tuberculosis Clinical Trial

— TBVOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379066
• Other study ID #: TB1
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: August 12, 2014
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2014
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
United States	Oxnard Specialty Clinic	Oxnard	California
United States	Pediatric Diagnostic Center	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Landon Pediatric Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of tuberculosis from bacterial plates	Tuberculosis will be identified form culture plates by the volatile organic compound signature	6 months	No