Evaluation of a new vancomycin dosage guideline in pediatric oncology patients.
Completed
- Conditions
- Antibioticum therapie10004018
- Registration Number
- NL-OMON40472
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Age 1 - 18 years
- Treatment with vancomycin i.v. for a clinically suspected or proven (catheter-related) infection
if age < 12 year: starting dose of 90 mg/kg/day (± 10%) divided in 4 doses, if age 12-18 year: starting dose of 60 mg/kg/day (± 10%) divided in 4 doses
- Diagnosed with a malignant disease for which treatment with chemotherapy is started
- Signed informed consent
Exclusion Criteria
- Inability to monitor drug levels during treatment
- Kidney function test (serum creatinine): 2x ULN (upper limit of normal)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter is the number of the therapeutic first vancomycin trough<br /><br>levels, when receiving a dose of 90 mg/kg/day. Furthermore, the number of sub-<br /><br>(< 10 mg/L) and supratherapeutic (> 15 mg/L) first trough levels is determined<br /><br>as well. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are the population pharmacokinetic parameters in<br /><br>these patients, which include both average values of clearance and volume of<br /><br>distribution and their intra- and interpatient variability. </p><br>