RecruitingPhase 4NCT05770622

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

The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)


Sponsor

Murdoch Childrens Research Institute

Enrollment

40 participants

Start Date

Nov 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 DaysMax Age: 90 Days

Inclusion Criteria2

  • Infants aged 0 - 90 days old
  • Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)

Exclusion Criteria6

  • 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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Interventions

OTHERFirst-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)

CALCULATOR: A 'First-dose trough dose adjustment calculator' was developed based on a population pharmacokinetic model. A participant's post-menstrual age, weight, creatinine, target trough concentration, dose, dosing interval and first-dose trough concentration (taken immediately before the second dose is due) are entered into the calculator. The calculator determines if a dose adjustment is required (based on whether the predicted steady-state trough concentration is \<10mg/L or \>20mg/L) and, if required, recommends a new adjusted dose.


Locations(4)

Royal Children's Hospital Melbourne

Melbourne, Victoria, Australia

Monash Newborn

Melbourne, Australia

Royal Hospital for Women

Sydney, Australia

The Children's Hospital at Westmead

Sydney, Australia

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NCT05770622


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