Dose Enhancement of Vancomycin IN Everyday Patients (DEVINE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Vancomycin Therapy
• Intervention / Treatment: Drug: DEVINE vancomycin regimen

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kathryn Daveson, BSc, MBBS, MPH; Phone Number: 42105 +61 2 6244 2222; Email: kdavesonwork@hotmail.com
• Study Contact Backup: Name: Karlee Johnston, B. Pharm; Phone Number: 42532 +61 2 6244 2222; Email: Karlee.Johnston@act.gov.au

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2605
      • Recruiting
      • The Canberra Hospital
      • Contact: Kathryn Daveson, BSc, MBBS, MPH; Phone Number: 2105 +612 62442222; Email: kdavesonwork@hotmail.com
      • Contact: Karlee Johnston, B. Pharm; Phone Number: 42532 +612 6244 2222; Email: Karlee.Johnston@act.gov.au
      • Principal Investigator: Kathryn Daveson, BSc, MBBS, MPH
      • Sub-Investigator: Karlee Johnston, B. Pharm.
      • Sub-Investigator: Miriam Lawrence, B. Pharm, M. Pharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DEVINE vancomycin regimen; This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen.	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.; Other Names: Pharmacokinetically derived vancomycin dosing regimen; Pharmacokinetic vancomycin regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Canberra Hospital
• Investigators: Principal Investigator: Kathryn Daveson, Bsc, MBBS, MPH, The Canberra Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2012
• Study Completion (ANTICIPATED): July 1, 2012

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 1, 2011
• First Posted (ESTIMATE): September 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 2, 2011
• Last Update Submitted That Met QC Criteria: September 1, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Vancomycin; Pharmacokinetics; Trough concentration
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: ETH.4.11.076