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. - MATADOR

Radboud University Medical Centre0 个研究点目标入组 30 人开始时间: 2013年11月4日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1.Patient receives immunosuppressive therapy for acuteGvHD grade II-IV or reduced in-tensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
•2.Subject is at least 18 of age on the day of providing informed consent.
•3.Has no signs or symptoms of invasive fungal disease
•4.If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
•5.Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD
•6.Is managed with a central venous catheter (preferably a quadruple Ar-row-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
•7.Subject is able and willing to sign the Informed Consent before screening evaluations.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation
•2.History of or current abuse of drugs, alcohol or solvents.
•3.Inability to understand the nature of the trial and the procedures re-quired.
•4.Has not previously participated in this trial.

发起方

Radboud University Medical Centre