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