Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)
VANCAPP
The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)
1 other identifier
interventional
40
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 sepsis
Started Nov 2024
Typical duration for phase_4 sepsis
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedStudy Start
First participant enrolled
November 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 20, 2026
April 1, 2026
2.1 years
March 5, 2023
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Target concentration at first steady-state concentration
The proportion of young infants achieving target trough serum vancomycin concentrations (10 to 20 mg/L) at first steady-state level when model-based dosing is used followed by early therapeutic drug monitoring (and dose adjustment) after the first dose
From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose
Secondary Outcomes (2)
Sub- and supratherapeutic concentrations at first steady-state concentration
From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose
Drug-related adverse effects
From first vancomycin dose (immediately after consent) to completion of vancomycin therapy (as determined by clinical team, an average of 5 days)
Study Arms (1)
Vancomycin first-dose trough dose adjustment calculation
EXPERIMENTALParticipants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. If the predicted steady-state level is within target range (10-20mg/L) the calculator will recommend continuing with the same dose. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Infants aged 0 - 90 days old
- Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Murdoch Childrens Research Institutelead
- Royal Children's Hospitalcollaborator
- Royal Hospital For Womencollaborator
- Sydney Children's Hospitals Networkcollaborator
- Monash Healthcollaborator
Study Sites (4)
Royal Children's Hospital Melbourne
Melbourne, Victoria, 3052, Australia
Monash Newborn
Melbourne, Australia
Royal Hospital for Women
Sydney, Australia
The Children's Hospital at Westmead
Sydney, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda Wilkins, MBBS
Royal Children's Hospital Melbourne, Murdoch Children's Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2023
First Posted
March 15, 2023
Study Start
November 10, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share