Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 7
- 主要终点
- plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
研究概览
简要总结
The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.
详细描述
Day 0 : onset of treatment by Ceftriaxone, following usual therapeutic process (French Guideline) From Day 0 to Day 4 : inclusion, clinical and biological data collection, electroencephalogram at baseline.
Two samples for ceftriaxone concentration monitoring :
- Trough concentration of ceftriaxone at steady state
- A random sample (population PK) At the end of ceftriaxone treatment : assessment of tolerance and efficacy of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Hospitalized adults patients,
- •age equal or above 18
- •Patients with Community or surgical acquired neurological infections, meningitis and others
- •Prescription of ceftriaxone >75mg/kg/d or >4g/d -
- •Subjects affiliated to French health insurance (social security)
- •Informed consent form signed
排除标准
- •Patient under guardianship
研究组 & 干预措施
Ceftriaxone treatment
ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
干预措施: Ceftriaxone treatment (Drug)
结局指标
主要结局
plasmatic concentration of ceftriaxone, measured at the steady state (after 48 hours of treatment at least).
时间窗: after at least 48 hours of ceftriaxone treatment
次要结局
- Neurological troubles(participants will be followed for the duration of ceftriaxone treatment, an expected average of two weeks)
- clinical evolution(participants will be followed for the duration of ceftriaxone treatment, an expected average of 2 weeks)