Vancomycin Dose Adjustments Comparing Trough Levels to The AUC0-24h/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Validation of The Research Protocol
研究概览
简要总结
This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated by the Bayesian approach rather than by a trough dosage. Randomization will be stratified according to infection severity. Approximately 60 subjects meeting all inclusion and no exclusion criteria will be randomized to have pharmacists perform vancomycin dose adjustments with AUC0-24h / MIC calculated by the Bayesian approach versus the trough dosage approach.
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
- None
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
- •At least 18 years of age;
- •Hospitalized patients
- •Suspected or confirmed infection;
- •Anticipated IV vancomycin treatment for 24 hours or more.
排除标准
- •Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis);
- •Treatment of vancomycin in continuous infusion;
结局指标
主要结局
Validation of The Research Protocol
时间窗: Through study completion, an average of 2 weeks
Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more
Evaluation of Recruitment
时间窗: Baseline
Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more
次要结局
- The number of adjustments required to reach the vancomycin target(During the vancomycin treatment)
- The proportion of patients who reach a therapeutic level in the first 48 hours(At 48 hours after the first dose of vancomycin)
- The number of vancomycin dosage level monitoring to reach the vancomycin target(During the vancomycin treatment)
- The difference between the initial prescribed dose and the dose suggested by the Bayesian software.(Baseline)
- Proportion of acute kidney injury(During the vancomycin treatment)
- The proportion of vancomycin dosage level monitoring in the vancomycin target(During the vancomycin treatment)
- Operational Impact(Immediately after the intervention)
- Average daily dose of vancomycin(Through study completion, an average of 2 weeks)
- Time to reach the vancomycin target(During the vancomycin treatment)
- The difference between the AUC calculated by the Bayesian method and the trapezoid method(During the vancomycin treatment)
研究者
Benoit Crevier
Principal Investigator
CR-CSSS Champlain-Charles-Le Moyne