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Completed

NCT Number: NCT01379066

Tuberculosis Volatile Organic Compounds

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

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

1 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxnard Specialty Clinic, Oxnard, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of tuberculosis from bacterial plates

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Landon Pediatric Foundation

Other

Registry information

Official study title

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

Acronym: TBVOC

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jun 23, 2011
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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