Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peritoneal/Plasma Penetration Ratio of Rezafungin
研究概览
简要总结
ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. In critically ill patients, drug levels can vary widely due to factors like surgery, inflammation, fluid resuscitation, or extracorporeal support, increasing the risk of underdosing. Rezafungin is a new antifungal agent with a long half-life and broad activity against Candida species, offering potential advantages in this setting. However, there is currently no data on its concentration or effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis. Its long half-life, coupled with repeated pharmacokinetic variations in critical care settings and the risk of insufficient concentrations, may hinder its use in this population.
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
- •age > 18 years
- •with a suspected intra-abdominal candidiasis requiring abdominal surgery
- •and receiving the administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery
- •and having abdominal drain for at least 2 days after the surgery
排除标准
- •death expected within 24h
- •decline to participate
结局指标
主要结局
Peritoneal/Plasma Penetration Ratio of Rezafungin
时间窗: From 0 to 3 hours after rezafungin administration
Penetration ratio of rezafungin will be calculated as the ratio of the area under the concentration-time curve from 0 to 3 hours (AUC₀-₃h) in peritoneal fluid compared to plasma in critically ill patients undergoing abdominal surgery for suspected or proven intra-abdominal candidiasis
次要结局
- Target Attainment in Peritoneal Fluid at the Time of Surgery(At the time of abdominal surgery (within the first 3 hours after rezafungin administration))
- Factors Associated with Target Attainment in Peritoneal Fluid(From 0 to 48 hours after the first rezafungin administration)
- Association Between Pharmacodynamic Target Attainment and Day-28 In-Hospital Mortality(From rezafungin administration to Day 28 post-treatment)
- Plasma Concentration-Time Profile of Rezafungin(From 0 to 168 hours after the first rezafungin administration)
- Postoperative Target Attainment in Plasma(From 0 to 168 hours after the first rezafungin administration)
- Peritoneal Concentration-Time Profile of Rezafungin(From 0 to 48 hours after the first rezafungin administration)