Dose Enhancement of Vancomycin IN Everyday Patients (DEVINE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by The Canberra Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kathryn Daveson, The Canberra Hospital
ClinicalTrials.gov Identifier:
NCT01427842
First received: August 31, 2011
Last updated: September 1, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Vancomycin Therapy
Drug: DEVINE vancomycin regimen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin

Resource links provided by NLM:


Further study details as provided by The Canberra Hospital:

Primary Outcome Measures:
  • Trough vancomycin concentration [ Time Frame: At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427842

Contacts
Contact: Kathryn Daveson, BSc, MBBS, MPH +61 2 6244 2222 ext 42105 kdavesonwork@hotmail.com
Contact: Karlee Johnston, B. Pharm +61 2 6244 2222 ext 42532 Karlee.Johnston@act.gov.au

Locations
Australia, Australian Capital Territory
The Canberra Hospital Recruiting
Canberra, Australian Capital Territory, Australia, 2605
Contact: Kathryn Daveson, BSc, MBBS, MPH    +612 62442222 ext 2105    kdavesonwork@hotmail.com   
Contact: Karlee Johnston, B. Pharm    +612 6244 2222 ext 42532    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         
Sponsors and Collaborators
The Canberra Hospital
Investigators
Principal Investigator: Kathryn Daveson, Bsc, MBBS, MPH The Canberra Hospital
  More Information

No publications provided

Responsible Party: Kathryn Daveson, Dr Kathryn Daveson, The Canberra Hospital
ClinicalTrials.gov Identifier: NCT01427842     History of Changes
Other Study ID Numbers: ETH.4.11.076
Study First Received: August 31, 2011
Last Updated: September 1, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Canberra Hospital:
Trough concentration
Vancomycin
Pharmacokinetics

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014