Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC/MIC ratio of Levofloxacin
研究概览
简要总结
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).
详细描述
Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.
研究设计
- 研究类型
- Observational
- 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
- •age> 18yrs
- •culture positive
- •diagnosis of MDR-TB
排除标准
- •Pregnancy
- •allergy to IV canula material
- •insertion of IV canula not possibele
结局指标
主要结局
AUC/MIC ratio of Levofloxacin
时间窗: after day 8 of treatment
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), \[AUC0-24h /MIC\], after administration of Levofloxacin.
Cmax/MIC ratio of Capreomycin
时间窗: after day 8 of treatment
The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, \[Cmax/MIC\], after administration of Capreomycin.
次要结局
- Volume of Distribution(after day 8 of treatment)
- Clearance(after day 8 of treatment)
研究者
JWC Alffenaar
PhD PharmD Clinical Pharmacologist Associate Professor
University Medical Center Groningen