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

Phase 1

• Conditions: Malignant childhood central nervous system tumors; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002813-37-AT
• Lead Sponsor: Department of Clinical Pharmacology, Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-24
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified