Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.
Royal Hospital for Women
Sydney, New South Wales, Australia
The Royal Children's Hospital
Melbourne, Victoria, Australia
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Time frame: 2 years
Drug-related adverse effects
the proportion of drug-related adverse effects with CIV compared to IIV
Time frame: 2 years
Time to achieve target levels
the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood
Time frame: 2 years
Clearance of vancomycin in young infants
Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
Time frame: 2 years
Volume of distribution of vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time frame: 2 years
Area under the concentration-time curve of vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time frame: 2 years
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Time frame: 2 years
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