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临床试验/NCT01379066
NCT01379066已完成不适用

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

Landon Pediatric Foundation2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Identification of tuberculosis from bacterial plates

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Heavy smoker
  • History of or active pulmonary disease other than tuberculosis

结局指标

主要结局

Identification of tuberculosis from bacterial plates

时间窗: 6 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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