SwEaTB - Diagnosing of Acute Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases
研究概览
简要总结
Sweat proteins are analysed to investigate differences in protein markers in patients with acute tuberculosis and other pulmonary diseases (pneumonia, Bronchitis, chronic obstructive pulmonary disease (COPD)) and healthy individuals. Differences in sweat protein markers in patients with positive and negative tuberculosis Enzyme-linked-immuno-Spot (EliSpot) are investigated.
Differences in sweat protein markers in the course of treatment in patients receiving tuberculostatic therapy are investigated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative
- •In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD)
- •Inclusion Criteria Healthy Donors:
- •negative for Quantiferon- TB Gold Plus Test or ELISpot
排除标准
- •Initiation of tuberculostatic therapy before baseline
- •Initiation of antibiotic therapy in patients with other pulmonary diseases > 6 hours before baseline
结局指标
主要结局
Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases
时间窗: Blood samples taken at baseline and 2 weeks after baseline
Distinction of patients with acute tuberculosis from patients with other pulmonary diseases by protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).
次要结局
- Differences in protein markers in patients with other pulmonary diseases(sweat and blood samples taken at baseline)
- change of protein markers during tuberculostatic therapy(sweat and blood sweat and blood samples taken at baseline and 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis)
- Differences in protein markers in patients with positive and negative tuberculosis ELISpot(sweat and blood samples taken at baseline)