Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Proportion of patients reaching target 24h AUC/MIC
研究概览
简要总结
The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
详细描述
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the individual patient is challenging.
Currently, the vancomycin dose is adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.
This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in non-critically ill adults, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney and a reduction in patient burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and legal representatives are blinded for the allocation to the intervention or standard-of-care arm until the end of study. The statistician is kept blinded until after data analysis.
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
- •18 years or older
- •admitted to a participating ward unit
- •a suspected or confirmed Gram positive infection
- •planned to start of started on intravenous continuous infusion vancomycin treatment
- •participant or legal representative signed the informed consent form
- •not previously enrolled in this trial
排除标准
- •serum creatinine level at inclusion is above 2.5 mg/dL
- •undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
- •patient death is deemed imminent and inevitable.
研究组 & 干预措施
Standard of Care Vancomycin treatment
Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period
干预措施: Vancomycin (Drug)
Vancomycin model-informed precision dosing
Area Under the Concentration-time curve ((AUC)/Minimal Inhibitory Concentration (MIC)-based model-informed precision dosing of vancomycin using a dosing calculator during 20 day study period
干预措施: Vancomycin model-informed precision dosing (Device)
Vancomycin model-informed precision dosing
Area Under the Concentration-time curve ((AUC)/Minimal Inhibitory Concentration (MIC)-based model-informed precision dosing of vancomycin using a dosing calculator during 20 day study period
干预措施: Vancomycin (Drug)
结局指标
主要结局
Proportion of patients reaching target 24h AUC/MIC
时间窗: 48 to 72 hours after start vancomycin treatment
Therapeutic AUC/MIC target range is 400-600
次要结局
- Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment(From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first)
- Proportion of patients reaching target 24h AUC/MIC(72 to 96 hours after start vancomycin treatment)
- Proportion of time within therapeutic target(From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first)