Dose Enhancement of Vancomycin IN Everyday Patients

Vancomycin Therapy Clinical Trial

— DEVINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01427842
• Other study ID #: ETH.4.11.076
• Status: Recruiting
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: September 1, 2011
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2011
• Source: The Canberra Hospital
• Contact: Kathryn Daveson, BSc, MBBS, MPH
• Phone: +61 2 6244 2222
• Email: kdavesonwork[@]hotmail.com
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Vancomycin Therapy

Intervention

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.

Locations

Country	Name	City	State
Australia	The Canberra Hospital	Canberra	Australian Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
The Canberra Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough vancomycin concentration	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.	At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin	No