A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Trough vancomycin concentration
研究概览
简要总结
Current Australian guidelines for vancomycin commonly underdoses individuals particularly in the first 48 hours.
The aim of the trial is to compare two dosing regimens; the current Australian guidelines versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of developing a new vancomycin dosing strategy that will enable patients to have more individualised and therapeutically efficacious treatment.
The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen increases the likelihood of achieving therapeutic trough levels of vancomycin within the first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin according to the current Antibiotic guidelines.
详细描述
DEVINE will be a randomised controlled trial of a new vancomycin dosing regimen against a control.
The control group regimen will receive the doses recommended by Therapeutic Guidelines - Antibiotics 2010. The intervention group will receive a dosing regimen that has been devised by modelling the antibiotic properties within the body over a large range of renal function and weight that will be more specific for the individual patient. They will receive this regimen for approximately 36-60 hours at which point they will have a vancomycin level blood test (a routine practice as part of their normal care). After this time the treating team will determine further dosing requirements.
All patients will be randomised at commencement of vancomycin with consent being obtained for the trial prior to the first dose of vancomycin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients in general wards requiring routine treatment with vancomycin
排除标准
- •GFR < 30mL/min(as measured by Cockcroft Gault equation)
- •Age < 16 yrs
- •Weight > 200kg
- •Patients dosing with Vancomycin other than BD according to national guidelines (ie continuous infusions, q6h etc)
- •Vancomycin infused at a rate other than 500mL/min
研究组 & 干预措施
DEVINE vancomycin regimen
This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen.
干预措施: DEVINE vancomycin regimen (Drug)
结局指标
主要结局
Trough vancomycin concentration
时间窗: At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin
The primary outcome measure will be the trough serum vancomycin concentration measured at steady state usually between 36 and 60 hours after the initial dose of vancomycin. This according to Australian targets is between 12-18mg/L.
次要结局
未报告次要终点
研究者
Kathryn Daveson
Dr Kathryn Daveson
The Canberra Hospital