The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate constant for tigecycline distribution
研究概览
简要总结
Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline
排除标准
- •severe liver dis- eases (e.g., Child-Pugh score C);
- •patients allergic to tetracycline and tigecycline;
- •those who have participated in other clinical trials, or those who are considered unsuitable by researchers;
- •pregnant women and lactating women.
结局指标
主要结局
Rate constant for tigecycline distribution
时间窗: Through study completion, an average of 3 days
Pharmacokinetics of tigecycline
Adverse events
时间窗: Through study completion, an average of 15 days
Drug-related adverse events and serious adverse events
Pharmacokinetics of tigecycline
时间窗: Through study completion, an average of 3 days
clearance in L/h
The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC).
时间窗: Through study completion, an average of 3 days
PD target
次要结局
- prothrombin time(Through study completion, an average of 3 days)
- activated partial thromboplastin time(Through study completion, an average of 3 days)
- international normalized ratio(Through study completion, an average of 3 days)
- fibrinogen levels in mg/dL(Through study completion, an average of 3 days)
- thrombin time(Through study completion, an average of 3 days)
- blood platelet count(Through study completion, an average of 3 days)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University