Dose Enhancement of Vancomycin IN Everyday Patients

Phase 2

• Conditions: Vancomycin Therapy
• Interventions: Drug: DEVINE vancomycin regimen

• Registration Number: NCT01427842
• Lead Sponsor: The Canberra Hospital

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

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-01
• Last Update Submitted: 2011-09-01
• Study First Posted: 2011-09-02
• Last Update Posted: 2011-09-02
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEVINE vancomycin regimen	DEVINE vancomycin regimen	This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia