Design of an Integrative Algorithm for Staging Tuberculosis to Improve Clinical Management.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Microbiological changes
研究概览
简要总结
Tuberculosis is a chronic infectious disease that affects 10 million people, 300 in the city of Barcelona, every year. With serious consequences at public health level, it is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by an integrative approach.
详细描述
Tuberculosis is a chronic infectious disease that affects 10 million people, there are 300 new cases 300 in the city of Barcelona, every year. Tuberculosis has serious consequences at public health level. It is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by a novel integrative approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TB diagnosis (all forms), microbiologically confirmed (by AFB+, GenXpert+ or Culture+)
- •Clinical management of the patients being done at Servicios Clínicos, Hospital Universitari Vall d'Hebron-Drassanes or Hospital Universitari Germans Trias i Pujol.
排除标准
- •Not consenting to data/samples donation
结局指标
主要结局
Microbiological changes
时间窗: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Changes in microbiological cultures
Clinical changes
时间窗: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR)
Changes in clinical status
次要结局
- Changes in Biomarkers values(timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR))
- Radiological Score Value(timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR))
- Changes in SGRQ score(timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR))
- Changes in Kessler-10 score(timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR))
- Changes in Health Quality of Life measures along time using BCN-Q questionnaire(timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR))