To determine the number of therapeutic first trough levels (vancomycin serum concentrations between 10 and 15 mg/L), when receiving a starting dose of 90 mg/kg/day. Furthermore, the number of subtherapeutic (serum concentration < 10 mg/L) and…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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-
(< 10 mg/L) and supratherapeutic (> 15 mg/L) first trough levels is determined
as well.
Secondary outcome
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.
Background summary
A recent retrospective study performed within the AMC demonstrated that a dose
of 60 mg/kg/day vancomycin produces subtherapeutic serum concentrations in a
majority of the pediatric oncologic patients. On basis of this data, pediatric
oncologists of AMC have increased the vancomycin starting dose to 90 mg/kg/day.
In this study we will determine the number of first therapeutic vancomycin
trough concentrations, when receiving a starting dose of 90 mg/kg/day.
Study objective
To determine the number of therapeutic first trough levels (vancomycin serum
concentrations between 10 and 15 mg/L), when receiving a starting dose of 90
mg/kg/day. Furthermore, the number of subtherapeutic (serum concentration < 10
mg/L) and supratherapeutic (serum concentration > 15 mg/L) trough serum
concentrations are determined as well. The secondary objectives of this study
are the assessment of population pharmacokinetic parameters.
Study design
This is a prospective observational cohort study with invasive measurements.
The patients will receive a vancomycin starting dose of 90 mg/kg/day. On basis
of clinical routine 1 trough concentration will be determined on which the dose
will be adjusted, if needed. If the first trough level is not within the
reference level (10 * 15 mg/L) a dosage advice is provided by the hospital
pharmacist. A second trough concentration will then be determined to confirm
the dosage advice. For this study, a maximum of 3 extra blood samples (3 times
50 microlitre) will be obtained. These samples may be obtained either from
leftover blood from other samples or via finger pricks.
Study burden and risks
The burden of this study includes a maximum of three finger pricks to obtain
three extra blood samples. If possible leftover blood from other samples will
be used instead. In total, 4 blood samples are needed to attain population
pharmacokinetic profile, of which one or two are obtained by clinical routine
sampling. The risk for the subjects is low.
This study will generate information regarding the adequacy of the new dose
regimen of vancomycin in pediatric oncology patients. The availability of the
population pharmacokinetic parameters is of benefit for the future improvement
of the vancomycin dosing regimen in this specific population.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44191.018.13 |