Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Clinical remission rate
研究概览
简要总结
The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female aged 18-75 years
- •Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
- •Empirical antimicrobial treatment is ineffective
- •Eravacycline application for ≥ 3 days
- •Understand and sign informed consent
排除标准
- •Urinary tract infection
- •Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
- •Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
- •Patients expected to survive for no longer than 48h.
结局指标
主要结局
Clinical remission rate
时间窗: At the end of treatment；2 weeks（estimated）
Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation
Microbiological efficacy
时间窗: From enrollment to the end of treatment at 28 days
Evaluate at the end of treatment and at post-treatment (discharge) in patients who met all clinical evaluation criteria and who had positive bacteriologic cultures prior to treatment, and bacterial clearance was calculated using the results of post-treatment follow-up (discharge) as the primary endpoint of evaluation.Performing safety observation (including coagulation dysfunction and other adverse reactions)
次要结局
- Develop Population Pharmacokinetic Model(From enrollment to the end of treatment at 28 days)
研究者
Lingai Pan
Associate Clinical Professor
Sichuan Provincial People's Hospital