Pharmacokinetics of Anidulafungin (Ecalta ®) Given Intravenously as Prophylaxis to Obese Patients With Risk of Invasive Fungal Infection Undergoing Gastric Bypass Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- anidulafungin area under the curve
研究概览
简要总结
Because anidulafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although anidulafungin is approved for the treatment of invasive candidiasis in adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as well as other echinocandins) in this specific patient population is still largely unknown. During endoscopic gastric bypass surgery, patients are more prone to various kinds of infection, justifying the prophylactic use of anidulafungin in this specific cohort of patients.
To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics in a normal-weight group.
详细描述
All obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. A PK curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12, 24, and 48 and (if feasible) 72 hours post infusion (n=12 samples). Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
- •Subject is at least 18 years of age on the day of screening.
- •If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.
- •Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
排除标准
- •Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
- •History of, or current abuse of drugs, alcohol or solvents.
- •Inability to understand the nature of the trial and the procedures required.
研究组 & 干预措施
Anidulafungin 100 mg single dose
100 mg single dose anidulafungin pre-surgery (gastric bypass)
干预措施: Anidulafungin 100mg single dose iv (Drug)
结局指标
主要结局
anidulafungin area under the curve
时间窗: 0-72 h after single dose
The primary outcome measurement will be the area under the plasma concentration-time curve (AUC) from time 0 to infinitive (inf) post infusion (AUC0- inf) value of anidulafungin. This will be determined by use of the log-linear trapezoidal rule. Peak plasma concentrations (Cmax) will be directly observed from the data. The elimination rate constant will be determined by linear regression of the terminal points of the log-linear plasma concentration time curve. Clearance (CL) will be calculated as dose/AUC0- inf.
次要结局
- Predict long-term exposure after repeated dosing by using a pharmacokinetic model of anidulafunign in obese patients by using AUC(0-inf), Cmax, elimination half-life and clearance.(PK curve on day 1-3)