Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cerebrospinal fluid concentration of anti-infective drugs
研究概览
简要总结
At least 50 patients with intracranial infection receiving anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime and avibactam were included in each group for pharmacokinetic study, and the outcomes and adverse events of intracranial infection treatment were observed.
详细描述
This study intends to establish a high performance liquid phase method to determine the concentration of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime abvibactam and other anti-infective drugs in cerebrospinal fluid, determine the concentration of cerebrospinal fluid in patients with central infection, and simultaneously determine the concentration of blood drugs at the same time point, optimize the clinical treatment plan by combining the concentration of cerebrospinal fluid and blood drugs, and explore the optimal concentration range of cerebrospinal fluid. At the same time, it can improve the cure rate of central infection, shorten the course of treatment and reduce the occurrence of adverse reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years old;
- •clinically diagnosed as central infection (cerebrospinal fluid culture is positive with clinical infection symptoms) or suspected as central infection (abnormal cerebrospinal fluid examination, such as hypoglycemia, < 50%; High protein, > 50 mg/dl; The number of cells increased with clinical infection symptoms, but no cerebrospinal fluid culture was positive)
- •receiving anti-infection treatment such as vancomycin or meropenem or linezolid or cefoperazone sulbactam;
- •Sign the informed consent form.
排除标准
- •There is no cerebrospinal fluid to determine the concentration;
- •allergic to drugs;
- •Other factors that researchers think are not suitable for inclusion.
研究组 & 干预措施
Patients with central infection
干预措施: The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined. (Drug)
结局指标
主要结局
Cerebrospinal fluid concentration of anti-infective drugs
时间窗: 2023-2026
We will establish a methodology for determining the concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam in cerebrospinal fluid by high performance liquid chromatography, and determine the drug concentrations in cerebrospinal fluid of patients with central infection, and simultaneously determine the blood drug concentrations at the same time point.
次要结局
- The incidence of adverse events caused by treatment(2023-2026)
- Treatment outcome of central infection(2023-2026)
研究者
Xueyan Cui
associate professor of pharmacy
Qianfoshan Hospital