Dose Enhancement of Vancomycin IN Everyday Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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

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Vancomycin Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DEVINE vancomycin regimen

This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen.

Group Type EXPERIMENTAL

DEVINE vancomycin regimen

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Pharmacokinetically derived vancomycin dosing regimen Pharmacokinetic vancomycin regimen

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No