NCT01427842

Dose Enhancement of Vancomycin IN Everyday Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Canberra Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Vancomycin Therapy

Interventions

Type	Name	Description
DRUG	DEVINE 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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-09-02
• Last updated: 2011-09-02

Locations

1 site across 1 country: Australia