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Trial registered on ANZCTR


Registration number
ACTRN12610001038088
Ethics application status
Approved
Date submitted
18/11/2010
Date registered
25/11/2010
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
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
None
Universal Trial Number (UTN)
U1111-1118-2034
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
Key inclusion criteria
requires treatment with either vancomycin, gentamicin or amikacin
Minimum age
No limit
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/02/2011
Actual
25/04/2011
Date of last participant enrolment
Anticipated
Actual
28/08/2012
Date of last data collection
Anticipated
Actual
29/08/2012
Sample size
Target
100
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 3053 0
New Zealand
State/province [1] 3053 0
Auckland

Funding & Sponsors
Funding source category [1] 258094 0
University
Name [1] 258094 0
University of Auckland
Country [1] 258094 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 257274 0
None
Name [1] 257274 0
Address [1] 257274 0
Country [1] 257274 0
Other collaborator category [1] 251660 0
Hospital
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
Hospital
Name [2] 251685 0
Middlemore Hospital
Address [2] 251685 0
Private Bag 93311
Otahuhu
Auckland 1640
New Zealand
Country [2] 251685 0
New Zealand

Ethics approval
Ethics application status
Approved
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
Hamilton
Ethics committee country [1] 260088 0
New Zealand
Date submitted for ethics approval [1] 260088 0
19/11/2010
Approval date [1] 260088 0
21/04/2011
Ethics approval number [1] 260088 0
CEN/11/02/03

Summary
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
Holford, S. D., et al. (2011). "Antibiotic Dosing Calculator in Neonates and Children Trial. http://www.paganz.org/default.asp?abstract=1153."
.
Public notes

Contacts
Principal investigator
Name 31931 0
Prof Nick Holford
Address 31931 0
Dept Pharmacology & Clinical Pharmacology
Faculty of Medical and Health Sciences
85 Park Road
Grafton
Auckland 1142
Country 31931 0
New Zealand
Phone 31931 0
+6499236730
Fax 31931 0
Email 31931 0
[email protected]
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
6499236730
Fax 15178 0
Email 15178 0
[email protected]
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
6499236730
Fax 6106 0
Email 6106 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Insufficient data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.