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

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 10, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

July 31, 2026

Conditions
SepsisInfectionsBacteremia
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.

Trial Locations (4)

3052

RECRUITING

Royal Children's Hospital Melbourne, Melbourne

Unknown

NOT_YET_RECRUITING

Monash Newborn, Melbourne

NOT_YET_RECRUITING

Royal Hospital for Women, Sydney

RECRUITING

The Children's Hospital at Westmead, Sydney

Sponsors
All Listed Sponsors
collaborator

Royal Children's Hospital

OTHER

collaborator

Royal Hospital For Women

OTHER

collaborator

Sydney Children's Hospitals Network

OTHER

collaborator

Monash Health

OTHER

lead

Murdoch Childrens Research Institute

OTHER