Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The incidence of vancomycin therapeutic serum trough concentrations
研究概览
简要总结
Study design:
Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.
详细描述
This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.
- •Sixty years and older.
排除标准
- •younger than 60 years old
- •Accepted blood purification therapy
- •Pregnancy
- •Positive HIV antibody titre
- •Had known or suspected tuberculosis or other infections caused by fungi at baseline.
研究组 & 干预措施
Study group
Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.
干预措施: Individualized therapy (Drug)
结局指标
主要结局
The incidence of vancomycin therapeutic serum trough concentrations
时间窗: before the fifth vancomycin dosage
The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group
次要结局
- Clinical success rate(Seven days after vancomycin withdrawal.)
- Vancomycin doses(At the end of vancomycin therapy, an average of 10 days.)
- Incidence of acute kidney injury(At the end of vancomycin treatment, an average of 10 days.)
研究者
Qingtao Zhou
Professor
Peking University Third Hospital