Therapeutic Drug Monitoring Combined With Quantitative Pharmacology for Dose Optimization of Rivaroxaban in Combination With Rifampicin in Patients With Periprosthetic Joint Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- plasma concentration of rivaroxaban
研究概览
简要总结
The goal of this observational study is to learn about exposure levels of rivaroxaban at different doses in patients with prosthetic joint infection combined with the use of rifampicin. Participants will be collected blood samples to determine rivaroxaban plasma concentration. The main question it aims to answer is to predict the dose adjustment of rivaroxaban combined with the use of rifampin.
详细描述
This study is a prospective observational study and does not interfere with the normal clinical diagnosis and treatment process. In the case of patients with periprosthetic infection with or without rifampicin, the blood concentration of rivaroxaban was monitored, and the data were further predicted and analyzed by statistical tests and physiological pharmacokinetic models, and suggestions were made for dose optimization.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients aged>18 years
- •The diagnosis was periprosthetic infection after joint replacement
- •Orthopedic operations such as revision of artificial joints, removal of prostheses, debridement, etc. for the treatment of periprosthetic infection
- •Rivaroxaban was used to prevent deep vein thrombosis after operation.
排除标准
- •Patients allergic to any excipient in rivaroxaban, rifampicin or tablets
- •Patients with clinically significant active bleeding
- •Patients with significant risk of bleeding
- •Patients with liver disease with coagulation abnormalities and clinical-related bleeding risk, including patients with cirrhosis who reached Child Pugh C grade
- •Pregnant women and breastfeeding women
- •Patients taking combined drugs affecting rivaroxaban metabolism
- •Patients who were unable or unwilling to cooperate with the study (Such as mental or memory disorders)
- •Patients discontinued without meeting study target days
- •Patients with severe renal insufficiency (creatinine clearance rate < 30ml / min)
结局指标
主要结局
plasma concentration of rivaroxaban
时间窗: 2-4 hours and 12-16 hours after 2-5 days of continuous dosing for rivaroxaban
HPLC-MS/MS method
次要结局
- incidence of adverse reactions(From admission to discharge, up to 3 week)
- effect indicator(From admission to discharge, up to 3 week)