Bacteremia, Infection, Sepsis
Conditions
Brief summary
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.
Interventions
DRUGContinuous infusion of vancomycin
Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.
Sponsors
Royal Children's Hospital
Royal Hospital For Women
Murdoch Childrens Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Days
Healthy volunteers
No
Inclusion criteria
\- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.
Exclusion criteria
* Infants with a corrected gestational age \< 25 weeks. * Allergy to vancomycin or other glycopeptide antibiotic * Vancomycin administered within the previous 72 hours * Renal impairment * Prior enrolment in the study * Need for drug that is incompatible with vancomycin (if no other IV line is available)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours) | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug-related adverse effects | 2 years | the proportion of drug-related adverse effects with CIV compared to IIV |
| Time to achieve target levels | 2 years | the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood |
| Area under the concentration-time curve of vancomycin in young infants | 2 years | Population pharmacodynamics modelling of vancomycin in young infants using NONMEM |
| Volume of distribution of vancomycin in young infants | 2 years | Population pharmacodynamics modelling of vancomycin in young infants using NONMEM |
| Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants | 2 years | Population pharmacodynamics modelling of vancomycin in young infants using NONMEM |
| Clearance of vancomycin in young infants | 2 years | Population pharmacokinetic modelling of vancomycin in young infants using NONMEM |
Countries
Australia
Outcome results
None listed