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Recruiting Phase 4 NCT05770622

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

Trial Parameters

Condition Sepsis
Sponsor Murdoch Childrens Research Institute
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 40
Sex ALL
Min Age 0 Days
Max Age 90 Days
Start Date 2024-11-10
Completion 2026-03
Interventions
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)

Brief Summary

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

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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