Pharmacokinetics of Micafungin (Mycamin ®) as Antifungal Prophylaxis Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- area under the curve
研究概览
简要总结
The primary objective of this trial is as follows:
To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin given daily.
The secondary objective of this trial is as follows:
To determine whether adequate exposure of micafungin is attained. To determine the safety of micafungin in this patient population
详细描述
Micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (HSCT) recipients and has proven as effective as fluconazole for prophylaxis. Whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. Sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. Decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages.
It will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
- •Subject is at least 18 of age on the day of providing informed consent.
- •Has no signs or symptoms of invasive fungal disease
- •If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- •Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
- •Is managed with a central venous catheter (preferably a quadruple Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
- •Subject is 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 micafungin preparation.
- •History of or current abuse of drugs, alcohol or solvents.
- •Inability to understand the nature of the trial and the procedures required.
- •Has not previously participated in this trial.
研究组 & 干预措施
alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
干预措施: alternate dosing (Other)
alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
干预措施: micafungin (Drug)
daily dosing
micafungin daily for 8 days
干预措施: daily dosing (Other)
daily dosing
micafungin daily for 8 days
干预措施: micafungin (Drug)
结局指标
主要结局
area under the curve
时间窗: day 4 and day 8
Full pharmacokinetic curves will be taken op Day 4 or 5 and Day 8 (micafungin). AUC of two dosing regimens will be compared.
次要结局
- population PK model(Day 4 and Day 8)
- adverse events(day 1- 11)