Vancomycin Therapy Clinical Trial
Official title:
A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin
Current Australian guidelines for vancomycin commonly underdoses individuals particularly in
the first 48 hours.
The aim of the trial is to compare two dosing regimens; the current Australian guidelines
versus a more appropriately modeled pharmacokinetic based regimen with the overall aim of
developing a new vancomycin dosing strategy that will enable patients to have more
individualised and therapeutically efficacious treatment.
The hypothesis is that dosing vancomycin according to a pharmacokinetically modeled regimen
increases the likelihood of achieving therapeutic trough levels of vancomycin within the
first 48 hours (or at steady state, whichever is sooner) compared to dosing vancomycin
according to the current Antibiotic guidelines.
DEVINE will be a randomised controlled trial of a new vancomycin dosing regimen against a
control.
The control group regimen will receive the doses recommended by Therapeutic Guidelines -
Antibiotics 2010. The intervention group will receive a dosing regimen that has been devised
by modelling the antibiotic properties within the body over a large range of renal function
and weight that will be more specific for the individual patient. They will receive this
regimen for approximately 36-60 hours at which point they will have a vancomycin level blood
test (a routine practice as part of their normal care). After this time the treating team
will determine further dosing requirements.
All patients will be randomised at commencement of vancomycin with consent being obtained
for the trial prior to the first dose of vancomycin
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment