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

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.

Conditions

• Sepsis
• Infections
• Bacteremia

Interventions

OTHER

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)

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.

Sponsors & Collaborators

• Royal Children's Hospital

  collaborator OTHER

• Royal Hospital For Women

  collaborator OTHER

• Sydney Children's Hospitals Network

  collaborator OTHER

• Monash Health

  collaborator OTHER

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Amanda Wilkins, MBBS · Royal Children's Hospital Melbourne, Murdoch Children's Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

0 Days

Max Age

90 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-10

Primary Completion

2026-12-31

Completion

2027-04-30

Countries

• Australia

Study Locations