Pattern Recognition of Volatile Organic Compounds (VOC) in Exhaled Breath for the Diagnosis of Pulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of correctly identified patients with tuberculosis
研究概览
简要总结
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide. Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis require advanced and expensive diagnostic methods that restrict their availability in resource limited countries where the burden of tuberculosis is highest. The development of rapid point of care diagnostics is required.
Published data confirm that trained African giant-pouched rats are able to identify M. tuberculosis cultures through olfactory recognition. A first trial using an electronic nose reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the recognition of tuberculosis remains unknown.
This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a potential for further development and fine tuning. A technical prototypic device of Siemens is used for pattern detection.
The study is comparing 3 groups of patients:
- patients with confirmed active pulmonary tuberculosis (n=20)
- patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial carcinoma) (n=20)
- healthy volunteers that do not work in the hospital or visit the hospital regularly Detailed data for all study subjects will be collected for this trial in order to eliminate confounding factors. Furthermore, detailed data of the surroundings of the patient, the surroundings of the technical device and of the operator will be captured.
Hypothesis:
The pattern of exhaled volatile organic compounds allows the detection of pulmonary tuberculosis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed pulmonary infection with M. tuberculosis (MTB) or other inflammatory disease of the lower respiratory tract (i.e. pneumonia, sarcoid, bronchial carcinoma) or healthy subject that is not employed or working at the study site
- •Oral and written consent to study participation
排除标准
- •Tuberculosis therapy >1 week
- •Inability to follow the study requirements
- •Patient in custodianship or guardianship
- •Other lung diseases that are not listed in the inclusion criteria.
结局指标
主要结局
Percentage of correctly identified patients with tuberculosis
时间窗: Day of admission to hospital
The VOC pattern is used to differentiate tuberculosis patients from patients with non-tuberculosis inflammatory lung disease and from healthy volunteers
次要结局
- Change in VOC pattern induced by storage temperature(At days 3, 5 and 7 after sample collection)
- Change in VOC pattern induced by storage for several days(At days 3, 5 and 7 after sample collection)
- Change in VOC pattern induced by tuberculosis therapy(After completion of recruitment)
研究者
Christian Herzmann
Head of Center for Clinical Trials
Research Center Borstel