Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease

Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2010年8月24日最近更新: 2012年3月19日

适应症

试验速览

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•1. Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS
•2. Subject is at least 18 and not older than 65 years of age on the day of the first dosing.
•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. Has an ALAT, ALAT, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
•6. Is not known to be hypersensitive to echinocandin antifungal agents
•7. Is managed with a quadruple central venous catheter (Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
•8. 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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
•2. Known of positive HIV test or hepatitis B or C test in history.
•3. History of QT time prolongation.
•4. History of or current abuse of drugs, alcohol or solvents.
•5. Inability to understand the nature of the trial and the procedures required.
•6. Has not previously participated in this trial

发起方

Radboud University Nijmegen Medical Centre