NCT01938417已完成不适用
Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute
University of Lausanne Hospitals0 个研究点目标入组 12 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Measurement of systemic tobramycin concentration
研究概览
简要总结
This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).
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
- •Adult (> or =18 years old) patients
- •Treatment with Osteoset® T
排除标准
- •Intravenous tobramycin
研究组 & 干预措施
adult patients treated with Osteoset® T (tobramycin sulfate)
10 g or 20 g of Osteoset® T
干预措施: tobramycin (Drug)
结局指标
主要结局
Measurement of systemic tobramycin concentration
时间窗: within 10 days after surgery
Develop a population pharmacokinetic model for tobramycin in patients treated with an active calcium sulfate bone substitute and to predict tobramycin systemic exposure under various dose and renal function levels.
次要结局
未报告次要终点
研究者
Francoise Livio, MD
Médecin associé
University of Lausanne Hospitals
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