Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
研究概览
简要总结
Determine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.
详细描述
Acronyms:
Tuberculosis (TB) Receiver Operating Curve (ROC) Common Terminology Criteria for Adverse Effects (CTCAE)
The aim of the study is to determine the diagnostic utility of the device 'Electronic Nose' for Pulmonary Tuberculosis. Prospective, Open, Three - Arm Controlled trial Study. Validation of the E-nose in urban settings to estimate the diagnostic accuracy of the E-nose using exhaled air in patients with Pulmonary TB in adults.
The patients who qualified for the study, according to the inclusion criteria, after consenting, will be guided through and oriented survey for risk factors, then a complete physical exam, and after that, the patient will breathe for 5 minutes trough the device, which stores the patient information, that later will be download to a computer and will be send to the server's manufacturer company, in Netherlands.
During and after the use of the device, we determine the adverse effects of the intervention, according to the CTCEA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accept to participate in the study through a signed informed consent approved by the Ethical Committee of our Institution.
- •More than 15 years old.
- •People with a culture positive for pulmonary TB
排除标准
- •Severe compromise of the general condition.
- •Not capable to exhaled through the E-nose.
- •No possibility to follow-up.
- •By discretion of the research team.
结局指标
主要结局
Diagnostic Accuracy of the electronic nose signal value to differentiate patients with Pulmonary TB.
时间窗: 1 year
Sensitivity, Specificity and Predictive Values; calculated with an ROC curve based on the Average processed-signal of the three electronic nose sensors. The signal is generated with a complex pattern recognition software, measuring the adsorption rate, desorption rate, and area under the curve generated by each sensor, expressed with a single value that ranges between -1 to +1.
Average Days needed to observed a negative result with the device after initiation of treatment.
时间窗: 60 days
Days-to-negative.
次要结局
- Number of Adverse Effects related to the used of the device, assess by the CTCAE(1 year)
研究者
Jacobus H. de Waard
Chief of Tuberculosis Laboratory
Universidad Central de Venezuela