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

Sponsor
Murdoch Childrens Research Institute
Study ID
NCT05770622
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bacteremia
  • Infections
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
0 Days - 90 Days
Healthy Volunteers
Not accepted

Interventions

  • 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) — OTHER
    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.

Study Details

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.

Key Dates

First listed
Mar 15, 2023
Start date
Nov 10, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Target concentration at first steady-state concentration [ Time Frame: From first vancomycin dose (immediately after consent) to steady state level taken at 24-48 hours post-first-dose ]

Central Contacts

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