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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518808-43-00

Enrollment

Registered

2024-12-11

Start date

2018-10-22

Completion date

Unknown

Last updated

2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain tumors

Brief summary

Area under the concentration-time curve (AUC) from 0 to last observed concentration (AUC0-τ), AUC from 0 to 24 hours (AUC0-24), concentration during therapy and at defined time points after end of therapy, Pharmacokinetic parameters describing rate/extent of distribution from plasma into CSF

Detailed description

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

Interventions

DRUGAugmentin 875 mg/125 mg Filmtabletten

DRUGCiprofloxacin Noridem 2 mg/ml Infusionslösung

DRUGEusaprim - Tabletten

DRUGCefotaxim-MIP 1 g – Pulver zur Herstellung einer Injektions- oder Infusionslösung

DRUGFomicyt 40 mg/ml Pulver zur Herstellung einer Infusionslösung

DRUGCefuroxim „Astro“ - Trockenstechampulle

DRUGCiproxin 500 mg Filmtabletten

DRUGCeftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions- /Infusionslösung

DRUGLinezolid Kabi 2 mg/ml Infusionslösung

DRUGVancomycin Hikma 1000 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

DRUGMeropenem Hikma 1g Pulver zur Herstellung einer Injektions-/Infusionslösung

DRUGGentamicin Sandoz 80 mg – Ampullen

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve (AUC) from 0 to last observed concentration (AUC0-τ), AUC from 0 to 24 hours (AUC0-24), concentration during therapy and at defined time points after end of therapy, Pharmacokinetic parameters describing rate/extent of distribution from plasma into CSF	—

Secondary

Measure	Time frame
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	—

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026