Malignant childhood central nervous system tumors
Conditions
Interventions
Trade Name: Augmentin
Product Name: Augmentin
Pharmaceutical Form: Coated tablet
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Department of Clinical Pharmacology, Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Area under the concentration-time curve (AUC) from 0 to last observed concentration (AUC0-t), AUC from 0 to 24 hours (AUC0-24), calculated by multiplying AUC0-t by 24/t, maximum concentration (Cmax), minimum concentration (Cmin), average concentration (Cav), time to maximum concentration (Tmax), half-life (t1/2), concentration during therapy and at defined time points after end of therapy (Cx). All variables will be calculated at steady-state both in CSF and in plasma.;Secondary Objective: - PK/PD relationships: ratio of the CSF AUC0-24 to the minimum inhibitory concentration (AUC0-24/MIC); percentage of the dosing interval during which drug concentrations in CSF exceed the MIC (%T>MIC); ratio of the peak CSF concentration to the MIC (Cmax/MIC) determination of target attainment for relevant pathogens - Determination of target attainment for relevant pathogens ;Primary end point(s): Levels of antibiotics in CSF and plasma identified;Timepoint(s) of evaluation of this end point: Levels of antibiotics in CSF and plasma identified | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Levels of antibiotics in CSF and plasma identified;Timepoint(s) of evaluation of this end point: Levels of antibiotics in CSF and plasma identified | — |
Countries
Austria
Contacts
Public ContactOffice
Department of Clinical Pharmacology, Medical University of Vienna
Outcome results
None listed