Actively Recruiting

Phase 4
Age: 0Days - 90Days
All Genders
NCT05770622

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

Led by Murdoch Childrens Research Institute · Updated on 2026-04-20

40

Participants Needed

4

Research Sites

124 weeks

Total Duration

On this page

Sponsors

M

Murdoch Childrens Research Institute

Lead Sponsor

R

Royal Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0Days - 90Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants aged 0 to 90 days old
  • Suspected infection requiring treatment with vancomycin for 48 hours or more as determined by the clinical team
Not Eligible

You will not qualify if you...

  • Infants with a corrected gestational age of less than 25 weeks
  • Infants weighing less than 500 grams
  • Known allergy to any glycopeptide antibiotic
  • Vancomycin administered within the previous 72 hours
  • Infants receiving any form of extracorporeal life support
  • Renal impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Royal Children's Hospital Melbourne

Melbourne, Victoria, Australia, 3052

Actively Recruiting

2

Monash Newborn

Melbourne, Australia

Not Yet Recruiting

3

Royal Hospital for Women

Sydney, Australia

Not Yet Recruiting

4

The Children's Hospital at Westmead

Sydney, Australia

Actively Recruiting

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Research Team

A

Amanda Wilkins, MBBS

CONTACT

A

Amanda Gwee, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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