The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cmax/MIC
研究概览
简要总结
To explore the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis/septic shock;To compare the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis and septic shock.
详细描述
This was a single-center study.Patients who were diagnosed with in invasive fungal infection receieved deoxycholic acid amphotericin B during the study period.The information was recored including the general condition, infection index, PK/PD index and drug-related side effects.
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
- •Patients age more than 18 years old; Meet the criteria of Sepsis 3.0; Admitted to ICU; Patients were suspected or diagnosis of IFI,doctors determined the use of deoxycholic acid amphotericin B.
排除标准
- •Serum creatinine≥221umol/L; Deoxycholic acid amphotericin B or amphotericin B liposome were used for the past 7 days; Patients being treated with rifampicin; Unable to tolerate treatment of deoxycholic acid amphotericin B; BMI<18.5 or >30; Tumors; Pregnancy; Estimated time of survival<24h; Patients who participated in other studies within 30 days.
研究组 & 干预措施
sepsis group
invasive fungal infection patients who were diagnosed sepsis accoreding to the sepsis 3.0 guidlines.
干预措施: Deoxycholic acid amphotericin B (Drug)
septic shock group
invasive fungal infection patients who were diagnosed septic shock accoreding to the sepsis 3.0 guidlines.
干预措施: Deoxycholic acid amphotericin B (Drug)
结局指标
主要结局
Cmax/MIC
时间窗: 14 days
PK/PD of Deoxycholic Acid Amphotericin B
次要结局
- AUC24h/MIC(14 days)
研究者
Songqiao Liu
MD
Southeast University, China