Pharmacokinetics of different antibiotics in cerebrospinal fluid in children with malignant brain tumors – a pilot study - Antibiotics in CSF

Department of Clinical Pharmacology, Medical University of Vienna0 个研究点目标入组 40 人开始时间: 2018年8月24日最近更新: 2018年10月15日

适应症

试验速览

暂无简介。

•Written informed consent of patients and/or parents
•Female or male, aged between 0 and 18 years (at time of initial diagnosis)
•CNS tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology
•Ongoing treatment with intravenous or oral antibiotics for therapeutic reasons
•Ongoing treatment with intrathecal administered chemotherapy via an Ommaya reservoir for therapeutic reasons
•Life expectancy of at least 8 weeks
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•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

•Treatment with intravenous or oral antibiotics or intrathecal therapy not indicated
•Contraindication for the puncture of the Ommaya reservoir or for administration of intrathecal chemotherapy (e.g. evidence of obstructive hydrocephalus or compartmentalization of CSF flow)
•Pregnancy or breast feeding

发起方

Department of Clinical Pharmacology, Medical University of Vienna