About this trial
A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.
Eligibility criteria
Qualifiers
Infants aged 0 - 90 days old
Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)
Disqualifiers
Infants with a corrected gestational age of less than 25 weeks
Infants weighing less than 500g.
Known allergy to any glycopeptide antibiotic
Vancomycin administered within the previous 72 hours
Trial design
Treatments tested in this trial
- First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)
Treatment groups
Sponsors and collaborators
Murdoch Childrens Research Institute
Lead sponsor
Royal Children's Hospital
Collaborator
Royal Hospital For Women
Collaborator
Sydney Children's Hospitals Network
Collaborator
Monash Health
Collaborator