2023-503411-15-00招募中4 期
A randomized trial investigating the superiority of TDM-optimized teicoplanin dosing versus standard of care
Stichting Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- • The difference in fraction of patients reaching pharmacokinetic target attainment of unbound teicoplanin concentrations at 5 days after start of treatment of the study group versus the control group.
研究概览
简要总结
To investigate target attainment at 5 days after treatment initiation in patients receiving TDM- guided dosing versus patients receiving standard dosing.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient is admitted to the Radboudumc
- •The patient is at least 18 years old on the day of inclusion.
- •The patient is treated with teicoplanin as part of standard care.
- •The patient or a representative is willing to sign the Informed Consent Form.
排除标准
- •The patient has previously participated in this study.
- •The patient receives any form of RRT other than CVVHD / CVVHDF.
- •Expected duration of teicoplanin therapy is less than 5 days.
- •Pregnant individuals
结局指标
主要结局
• The difference in fraction of patients reaching pharmacokinetic target attainment of unbound teicoplanin concentrations at 5 days after start of treatment of the study group versus the control group.
• The difference in fraction of patients reaching pharmacokinetic target attainment of unbound teicoplanin concentrations at 5 days after start of treatment of the study group versus the control group.
次要结局
- • Time until reaching target attainment.
- • Incidence of clinical failure at day 30.
- • Total number of days in hospital
- • Incidence of AKI during teicoplanin treatment
研究者
Nynke Jager
Scientific
Stichting Radboud University Medical Center
研究点 (1)
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