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Dose Enhancement of Vancomycin IN Everyday Patients

Information source: The Canberra Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vancomycin Therapy

Intervention: DEVINE vancomycin regimen (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Canberra Hospital

Official(s) and/or principal investigator(s):
Kathryn Daveson, Bsc, MBBS, MPH, Principal Investigator, Affiliation: The Canberra Hospital

Overall contact:
Kathryn Daveson, BSc, MBBS, MPH, Phone: +61 2 6244 2222, Ext: 42105, Email: kdavesonwork@hotmail.com


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.

Clinical Details

Official title: A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Trough vancomycin concentration

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


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Kathryn Daveson, BSc, MBBS, MPH, Phone: +61 2 6244 2222, Ext: 42105, Email: kdavesonwork@hotmail.com

The Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia; Recruiting
Kathryn Daveson, BSc, MBBS, MPH, Phone: +612 62442222, Ext: 2105, Email: kdavesonwork@hotmail.com
Karlee Johnston, B. Pharm, Phone: +612 6244 2222, Ext: 42532, Email: Karlee.Johnston@act.gov.au
Kathryn Daveson, BSc, MBBS, MPH, Principal Investigator
Karlee Johnston, B. Pharm., Sub-Investigator
Miriam Lawrence, B. Pharm, M. Pharm, Sub-Investigator
Additional Information

Starting date: August 2011
Last updated: September 1, 2011

Page last updated: August 23, 2015

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