NCT03409315Unknown不适用
Prospective Evaluation of impRoving Fluoroquinolone Exposure Using Centralized Tdm in TB Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 13
- 主要终点
- Feasibility of centralized TDM
研究概览
简要总结
Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.
In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.
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
- •Pulmonary MDR-TB
- •Sputum smear and sputum culture positive at baseline
- •Oral administration of either moxifloxacin or levofloxacin
- •Written informed consent (for use of the medical data)
排除标准
- •Pregnancy or breast feeding
结局指标
主要结局
Feasibility of centralized TDM
时间窗: 1 week
Turn-around time between plasma sampling and receiving dosing advice
次要结局
- Impact of centralized TDM(2 months)
研究者
Jan-Willem C Alffenaar
PhD, PharmD
University Medical Center Groningen
研究点 (13)
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