We will obtain pharmacokinetic data of cefuroxime, vancomycin, gentamicin, ampicillin, linezolid, piperacillin/tazobactam and cefazolin in cerebrospinal fluid and plasma of children with external ventricular drain. The children will be receiving the drug for treatment of infection at the discretion of their treating physicians on the neonatal intensive care unit.
Conditions
Interventions
Trade Name: Cefuroxim
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Cefuroxime SODIUM
CAS Number: 55268-75-2
Other descriptive name: CEFUROXIME
Concentration uni
Sponsors
Department of Clinical Pharmacology/Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female or male, aged between 3 days and 3 months (study groups with cefuroxime, vancomycin, ampicillin, piperacillin/tazobactam and cefazolin) • Female or male, aged between 7 days and 3 months (study groups with gentamicin and linezolid) • External ventricular drain in place • Hospitalisation on an intensive care or intermediate care unit • Clinical diagnosis of infection, requiring antibiotic therapy or antibiotic therapy as infection prophylaxis • Current or planned therapy with cefuroxime, gentamicin, vancomycin, ampicillin, linezolid, piperacillin/tazobactam or cefazolin as treatment or prophylaxis of a bacterial infection (any localisation). • Signed informed consent by at least one parent or legal representative Are the trial subjects under 18? yes Number of subjects for this age range: 56 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: • Allergy or hypersensitivity against study drug • Severe renal impairment, defined by a serum creatinine level of more than 200% of age-specific reference values, or urinary output 12 hours • Any disease considered a risk for proper performance of the study or risks to the patient, at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to determine the pharmacokinetics of cefuroxime, vancomycin, gentamicin, ampicillin, linezolid, piperacillin/tazobactam and cefazolin in CSF and plasma of neonates. To reach this goal we will perform PK measurements in children on a neonatal intensive care unit in plasma and CSF and calculate pharmacokinetic/pharmacodynamic (PK/PD) parameters considering currently established/discussed breakpoints. ;Secondary Objective: Exploratory assess the appropriateness of existing dosing therapies of cefuroxime, vancomycin, gentamicin, ampicillin, linezolid, piperacillin/tazobactam and cefazolin in CSF and plasma of neonates;Primary end point(s): Maximum concentration (Cmax), time to maximum concentration (tmax), area under the concentration time curve from zero to last observed concentration (AUC0-t), half-life (t1/2) in CSF;Timepoint(s) of evaluation of this end point: defined time points during and after therapy with the study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Maximum concentration (Cmax), time to maximum concentration (tmax), area under the concentration time curve from zero to last observed concentration (AUC0-t), half-life (t1/2), total body clearance (CL), apparent volume of distribution (VD) in plasma; penetration ratio calculated as CSF concentration (Cmax and AUC0-t, respectively) divided by plasma concentration - PK/PD parameters Cmax/MIC, AUC/MIC, T>MIC in CSF and plasma (if applicable) considering currently established/discussed susceptibility breakpoints of relevant pathogens - probability of target attainment for relevant pathogens - collection of adverse events during study participation;Timepoint(s) of evaluation of this end point: defined time points during and after therapy with the study drug | — |
Countries
Austria
Contacts
Public ContactOffice
Department of Clinical Pharmacology/Medical University of Vienna
Outcome results
None listed