Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-90
SponsorMurdoch Childrens Research Institute

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

40 Participants
are divided into 1 treatment group

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