Clinical Trials Directory

Trials / Completed

CompletedNCT01379066

Tuberculosis Volatile Organic Compounds

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

Status
Completed
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Landon Pediatric Foundation · Academic / Other
Sex
All
Age
1 Year – 40 Years
Healthy volunteers
Accepted

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

Conditions

Timeline

Start date
2009-08-01
Primary completion
2009-12-01
Completion
2010-12-01
First posted
2011-06-23
Last updated
2014-08-13

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01379066. Inclusion in this directory is not an endorsement.