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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Antibiotic Dosing Calculator for Neonates and Children Trial
Scientific title
A study in premature and full term neonates and children using non-blinded randomized intervention to compare a standard protocol dose versus dose calculator predicted dose of either vancomycin, amikacin or gentamicin with outcome measured by closeness to target concentration
Secondary ID [1] 253118 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 258680 0
Condition category
Condition code
Infection 258826 258826 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
A comparison will be made of standard of care protocol dose method with a web based pharmacokinetic model based dose calculator. The dose calculator uses primarily weight, post-menstrual age and serum creatinine. Additional factors include use of mechanical ventilation, inotropes and non-steroidal anti-inflammatory drugs. It is used to predict the initial dosing of vancomycin, amikacin or gentamicin. The intervention is applied once when initial dosing is decided by the clinician.
Intervention code [1] 257639 0
Treatment: Devices
Comparator / control treatment
The study will be performed at 3 sites. Each site has its own protocol for standard of care dosing of vancomycin, amikacin and gentamicin.
Control group

Primary outcome [1] 259688 0
The primary endpoint is how close the measured concentration is to the target concentration. Concentrations are measured in serum using standard clinical chemistry laboratory procedures.
Timepoint [1] 259688 0
The first measured drug concentration is decided by the clinician in charge. There are guidelines for timing of the concentration which is most commonly at the time of the 3rd dose.
Secondary outcome [1] 266385 0
Clinician preference for standard of care dosing or web based dose calculator dosing will be assessed using a standard questionnaire.
Timepoint [1] 266385 0
The secondary endpoint will be assessed at the end of the trial (12 months) or if a clinician who has participated leaves the clinical site before the trial finishes.

Key inclusion criteria
requires treatment with either vancomycin, gentamicin or amikacin
Minimum age
No limit
Maximum age
2 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomized allocation
Allocation determined by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3053 0
New Zealand
State/province [1] 3053 0

Funding & Sponsors
Funding source category [1] 258094 0
Name [1] 258094 0
University of Auckland
Address [1] 258094 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 258094 0
New Zealand
Primary sponsor type
University of Auckland
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
New Zealand
Secondary sponsor category [1] 257274 0
Name [1] 257274 0
Address [1] 257274 0
Country [1] 257274 0
Other collaborator category [1] 251660 0
Name [1] 251660 0
Auckland hospital
Address [1] 251660 0
Auckland City Hospital/
Te Papakainga Atawhai Campus
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country [1] 251660 0
New Zealand
Other collaborator category [2] 251685 0
Name [2] 251685 0
Middlemore Hospital
Address [2] 251685 0
Private Bag 93311
Auckland 1640
New Zealand
Country [2] 251685 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260088 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 260088 0
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Ethics committee country [1] 260088 0
New Zealand
Date submitted for ethics approval [1] 260088 0
Approval date [1] 260088 0
Ethics approval number [1] 260088 0

Brief summary
Test of a pharmacokinetically guided dose calculator for dosing of vancomycin, gentamicin or amikacin in premature neonates, neonates and infants
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31931 0
Address 31931 0
Country 31931 0
Phone 31931 0
Fax 31931 0
Email 31931 0
Contact person for public queries
Name 15178 0
Nick Holford
Address 15178 0
Dept Pharmacology & Clinical Pharmacology
85 Park Road, Auckland, Private Bag 90219
Country 15178 0
New Zealand
Phone 15178 0
Fax 15178 0
Email 15178 0
Contact person for scientific queries
Name 6106 0
Nick Holford
Address 6106 0
Dept Pharmacology & Clinical Pharmacology
85 Park Road, Auckland, Private Bag 90219
Country 6106 0
New Zealand
Phone 6106 0
Fax 6106 0
Email 6106 0

No information has been provided regarding IPD availability
Summary results
No Results