Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
研究概览
简要总结
Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infections
- •Indication for oral switch to ofloxacin
排除标准
- •Patient refusing to participate in the study
- •Patient under guardianship or curators or deprived of public rights
- •Any liver or biliary injury
- •Any contraindications to ofloxacin
结局指标
主要结局
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
时间窗: day 3
Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections
次要结局
未报告次要终点