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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 3 months
Healthy Volunteers: f
View:

• Infants aged 0 - 90 days old

• Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)

Locations
Other Locations
Australia
Monash Newborn
NOT_YET_RECRUITING
Melbourne
Royal Children's Hospital Melbourne
RECRUITING
Melbourne
Royal Hospital for Women
NOT_YET_RECRUITING
Sydney
The Children's Hospital at Westmead
RECRUITING
Sydney
Contact Information
Primary
Amanda Wilkins, MBBS
amanda.wilkins@rch.org.au
9345 5522
Backup
Amanda Gwee, MBBS
amanda.gwee@rch.org.au
9345 5522
Time Frame
Start Date: 2024-11-10
Estimated Completion Date: 2026-07
Participants
Target number of participants: 40
Treatments
Experimental: Vancomycin first-dose trough dose adjustment calculation
Participants 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.
Related Therapeutic Areas
Sponsors
Collaborators: Monash Health, Royal Hospital For Women, Royal Children's Hospital, Sydney Children's Hospitals Network
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov