A Population PK Study Into Teicoplanin in Intensive Care and Haematology Patients - a Strategy Towards Model Informed Precision Dosing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total drug clearance
研究概览
简要总结
Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function.
In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK model for Bayesian dose individualization.
详细描述
Bacterial infection with coagulase-negative staphylococci (CNS) or methicillin resistant and sensitive staphylococcus aureus(MRSA/MSSA) indicates poor prognosis and increased mortality in critically ill patients.
With the current emergence of glycopeptide-intermediate sensitive Staphylococcus aureus strains, personalized dosing of teicoplanin is of utmost importance to preserve the current therapeutic armamentarium.
Teicoplanin is considered equipotent to vancomycin, albeit safer with minimal nephrotoxicity. It is estimated that 50% of all critically ill patients treated with teicoplanin does not reach target exposure. This is the major driver for treatment failure and development of resistance and dose individualization will overcome this problem.
Our project is aimed at developing and implementing a personalized dosing strategy for teicoplanin, to prevent development of glycopeptide resistance and allow safe treatment of glycopeptide intermediate sensitive bacteria.
In a prospective clinical study, critically ill patients (defined as ICU and hematology patients) who receive teicoplanin as standard care for antimicrobial treatment will be eligible for inclusion. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through an indwelling central venous catheter or an arterial line (9 samples per patient). Teicoplanin total and free drug concentrations will be measured using a validated analytical assay. A total of 30 patients will be included.
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
- •The patient is admitted to the ICU of the haematology department
- •The patient is at least 18 years of age on the day of inclusion
- •Is managed with a central venous catheter or arterial line
- •Is treated with teicoplanin as a part of standard care
排除标准
- •Has previously participated in this study
- •Patient is admitted to the haematology department and receives any form of RRT other than continuous venovenous hemofiltration (CVVH).
结局指标
主要结局
Total drug clearance
时间窗: 4 days
Pharmacokinetic curves will be taken
次要结局
- Area under the curve(4 days)
- Volume of distribution(4 days)