NCT01379066已完成不适用
Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph
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
- 是
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
研究点 (2)
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