Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
研究概览
简要总结
The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.
详细描述
The secondary objectives of this study are:
- Determine whether the current recommended doses of caspofungin achieve the Pharmacokinetic/Pharmacodynamic (PK/PD) target for this molecule.
- Determine whether the current recommended doses of micafungin achieve the PK / PD target for this molecule
- Describe the peritoneal concentrations of echinocandins in secondary peritonitis complicated with septic shock
- Identify via modeling PK / PD parameters and based on monte Carlo simulations the optimal dosing regimen for caspofungin and micafungin in this population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is 18 years of age or older
- •The patient has beed admitted to the ICU for septic shock accompanying secondary peritonitis
- •Patient requiring antifungal treatment via echinocandins (caspofungin or micafungin)
- •A venous or arterial access for blood sampling is already in place for routine care
排除标准
- •The patient is participating in an interventional study that may affect the results of the present study, or has participated in such a study within the past 3 months
- •The patient is under judicial protection, or is an adult under guardianship
- •The patient is pregnant, parturient or breastfeeding
- •Moribund patient
- •Known positive serology for human immunodeficiency virus (HIV)
- •Known positive serology for hepatitis C
- •Known diagnosis for tuberculosis
研究组 & 干预措施
The study population
The study population consisted of patients admitted to the ICU for septic shock associated with secondary peritonitis and requiring antifungal therapy via echinocandins (micafungin or caspofungin).
干预措施: Echinocandins (Drug)
结局指标
主要结局
The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration
时间窗: Days 3-5
Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration
时间窗: Days 3-5
The minimum concentration for plasmatic antifungal treatment concentrations
时间窗: Days 3-5
The area under the curve for plasmatic antifungal treatment concentrations
时间窗: Days 3-5
Antifungal treatment plasmatic clearance (L/h)
时间窗: Days 3-5
The maximum concentration for plasmatic antifungal treatment concentrations
时间窗: Days 3-5
次要结局
- The area under the curve for peritoneal antifungal treatment concentrations(Days 3-5)
- The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio(Days 3-5)
- The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin(Days 3-5)
- The target Pharmacokinetic/Pharmacodynamic ratio for micafungin(Days 3-5)
- The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio(Days 3-5)
- The maximum concentration for peritoneal antifungal treatment concentrations(Days 3-5)
- The minimum concentration for peritoneal antifungal treatment concentrations(Days 3-5)