Vancomycin Monitoring: Is AUC Monitoring Appropriate for More Than Just Serious MRSA Infections?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- • Determine differences in efficacy/clinical outcome and re-admission rates of AUC monitoring compared to trough monitoring in severe or deep-seeded infections (pneumonia, endocarditis, osteomyelitis or bacteremia)
研究概览
简要总结
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA) infections.1 Notable adverse effects of intravenous vancomycin include nephrotoxicity, ototoxicity and hypersensitivity reactions. Given its pharmacokinetic profile, therapeutic drug monitoring is essential in determining the therapeutic efficacy of vancomycin as well as for avoiding nephrotoxicity.
详细描述
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA) infections.1 Notable adverse effects of intravenous vancomycin include nephrotoxicity, ototoxicity and hypersensitivity reactions. Given its pharmacokinetic profile, therapeutic drug monitoring is essential in determining the therapeutic efficacy of vancomycin as well as for avoiding nephrotoxicity.
The 2020 guidelines continue to enforce AUC/MIC as the preferred PK/PD parameter, but now recommend utilizing vancomycin peak and trough concentrations to target an AUC/MIC of 400-600 mg*h/L for serious MRSA infections. Although this AUC goal is not new, the 2009 consensus guidelines previously recommended trough only monitoring as a simplistic surrogate marker for attaining this AUC goal. Furthermore, the most accurate way of calculating AUC requires obtaining two steady state vancomycin serum concentrations over one dosing period. In this way, AUC guided monitoring requires more pharmacist and nursing time, the use of more hospital resources and additional cost to the patient.
As was true of the 2009 guidelines, the 2020 guidelines also leave certain questions unanswered. The paucity and conflicting data of vancomycin monitoring in patients with non-serious MRSA infections (skin and soft tissue infections, urinary tract infections, etc.), methicillin-sensitive Staphylococcus aureus (MSSA) infections and non-staphylococcal pathogen infections has left no guidance on the ideal vancomycin PK/PD targets in these patient populations. A literature search of AUC/MIC monitoring in patients with streptococcal and enterococcal infections yielded very few studies in patients with enterococcal infections and no studies in patients with streptococcal infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized from June 2020- January
- •18 years and older
- •At least 1 vancomycin trough concentration drawn at steady state
- •Organism with an MIC of 2 mg/L, if vancomycin was continued and in whom a steady state trough concentration was obtained
排除标准
- •Patients with end stage renal disease (on hemodialysis or peritoneal dialysis) or on continuous renal replacement therapy
结局指标
主要结局
• Determine differences in efficacy/clinical outcome and re-admission rates of AUC monitoring compared to trough monitoring in severe or deep-seeded infections (pneumonia, endocarditis, osteomyelitis or bacteremia)
时间窗: up to 1 year
Readmission rate of AUC monitoring compared to trough monitoring. Re-admission within 30 days will be classified as due to previous infection or all-cause.
Efficacy of trough and AUC vancomycin monitoring
时间窗: up to 1 year
To compare the efficacy of targeting troughs of 10-20 mg/L vs targeting AUC of 400-600 for vancomycin monitoring without the use of vancomycin peak serum concentrations. o AUC will be calculated via the trapezoidal method.o Troughs will be stratified in the following categories: \< 10 mg/L, 10-15 mg/L, 15-20 mg/L and \> 20 mg/L.
次要结局
未报告次要终点