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

RecruitingPhase 4Ages 0 Days - 90 DaysAllMurdoch Childrens Research Institute
NCT05770622 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Infants aged 0 - 90 days old * Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team) Exclusion Criteria: * 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 * Infants receiving any form of extracorporeal life support * Renal impairment
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What it tests

  • 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)
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Where

4 sites
Royal Children's Hospital Melbourne
Melbourne, Australia
Monash Newborn
Melbourne, Australia
Royal Hospital for Women
Sydney, Australia
The Children's Hospital at Westmead
Sydney, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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