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Clinical Trials/NCT01379066
NCT01379066CompletedNot Applicable

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

Landon Pediatric Foundation2 sites in 1 country15 target enrollmentStarted: August 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
Identification of tuberculosis from bacterial plates

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Year to 40 Years (Child, Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Identification of tuberculosis from bacterial plates

Time Frame: 6 months

Tuberculosis will be identified form culture plates by the volatile organic compound signature

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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