Vancomycin Therapy
Conditions
Keywords
Trough concentration, Vancomycin, Pharmacokinetics
Brief summary
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.
Detailed description
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
Interventions
DRUGDEVINE vancomycin regimen
The dosing regimen varies by weight and height and by initial or ongoing dose prescribed. The loading dose is based on actual volume of distribution of vancomycin whilst the ongoing doses are based on creatinine clearance.
Sponsors
The Canberra Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients in general wards requiring routine treatment with vancomycin
Exclusion criteria
* GFR \< 30mL/min(as measured by Cockcroft Gault equation) * Age \< 16 yrs * Weight \> 200kg * Patients dosing with Vancomycin other than BD according to national guidelines (ie continuous infusions, q6h etc) * Vancomycin infused at a rate other than 500mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough vancomycin concentration | At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin | The primary outcome measure will be the trough serum vancomycin concentration measured at steady state usually between 36 and 60 hours after the initial dose of vancomycin. This according to Australian targets is between 12-18mg/L. |
Countries
Australia
Contacts
Primary ContactKathryn Daveson, BSc, MBBS, MPH
Backup ContactKarlee Johnston, B. Pharm
Outcome results
None listed