Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 主要终点
- The plasma and bronchoalveolar lavage fluid concentrations of linezolid
研究概览
简要总结
The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.
详细描述
A wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. To the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. Severe pneumonia patients known or suspected to be caused by Gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. In an in vitro PK Model, concentration-time curve is drawn to calculate %T>MIC or AUC0-24h/MIC. Linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 years old and 75 years old;
- •Admitted to the ICU;
- •Expectation, in the opinion of the investigator, that the patients' infection will require ICU stay more than 3 days;
- •Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;
- •Severe pneumonia known or suspected to be caused by Gram-positive pathogens;
- •Expected to treat with linezolid.
排除标准
- •Unable to take bronchoalveolar lavage via bronchofiberscopy;
- •Allergy, hypersensitivity or a serious reaction to linezolid;
- •Treatment with linezolid during the previous 72 hours;
结局指标
主要结局
The plasma and bronchoalveolar lavage fluid concentrations of linezolid
时间窗: Baseline, Day 3, Day 7
The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state
次要结局
- Bacterial eradication(Baseline, Day 3, Day 7)
研究者
Jingyuan,Xu
chief doctor
Southeast University, China