A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Fraction of participants that reaches therapeutic exposure after 5 days of treatment
研究概览
简要总结
Value of TDM for teicoplanin is not well defined. In this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin TDM-optimized using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment.
详细描述
Teicoplanin is a glycopeptide antibiotic that is frequently used in the treatment of gram-positive bacterial infections.
The glycopeptide antibiotic vancomycin is currently the first choice of treatment against methicillin-resistant Staphylococcus aureus (MRSA), but teicoplanin is found to have a similar efficacy while showing less nephrotoxicity (4.8% vs 10.7%). Vancomycin dosing is based on therapeutic drug monitoring (TDM). In contrast to vancomycin, value of TDM for teicoplanin is not as well defined. In this study the superiority of teicoplanin TDM-optimized dosing using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment will be investigated. The overall aim of this research is to improve antibiotic treatment with teicoplanin to allow safe and optimal treatment of glycopeptide susceptible strains and to prevent de novo development of resistance.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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, haematology, gastroenterology or orthopaedics department.
- 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 renal replacement criteria (RRT) other than CVVHD / CVVHDF.
- Expected duration of teicoplanin therapy is less than 5 days.
- The patient is pregnant
研究组 & 干预措施
Model Informed Precision Dosing (MIPD) guided Therapeutic Drug Monitoring(TDM)
Participants start on standard of care dosing. After 2 days blood samples will be analysed and exposure will be determined using MIPD. Wherever necessary dose adjustments will be made.
干预措施: Teicoplanin (Drug)
Standard of care
Participants receive teicoplanin on discretion of the doctor
结局指标
主要结局
Fraction of participants that reaches therapeutic exposure after 5 days of treatment
时间窗: 5-7 days after initiation of teicoplanin therapy
Unbound teicoplanin exposure after 5 days will be determined and compared to the predefined therapeutic window of 70-150 mg/L\*24h
次要结局
- Time until reaching target attainment(5-7 days after initiation of teicoplanin therapy)
- Days in hospital(30 days after initiation of teicoplanin therapy)
- Clinical failure(30 days after initiation of teicoplanin therapy)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05914467
- 其他研究编号
- 113998, 2023-503411-15-00
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (7个月前)
- 研究完成日期
- (7个月前)
- 最近核实
- (去年)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否