Evaluation of a new vancomycin dosage guideline in pediatric oncology patients.

Evaluation of a new vancomycin dosage guideline in pediatric oncology patients. - Vancomycin dosing in pediatric oncology patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40472

Enrollment

Registered

2013-07-19

Start date

2014-06-24

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Antibioticum therapie

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Age 1 - 18 years - Treatment with vancomycin i.v. for a clinically suspected or proven (catheter-related) infection if age

Exclusion criteria

Exclusion criteria: - Inability to monitor drug levels during treatment - Kidney function test (serum creatinine): 2x ULN (upper limit of normal)

Design outcomes

Primary

Measure	Time frame
Main study parameter is the number of the therapeutic first vancomycin trough levels, when receiving a dose of 90 mg/kg/day. Furthermore, the number of sub- ( 15 mg/L) first trough levels is determined as well.	—

Secondary

Measure	Time frame
Secondary study parameters are the population pharmacokinetic parameters in these patients, which include both average values of clearance and volume of distribution and their intra- and interpatient variability.	—

Countries

Netherlands

Outcome results