Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose Enhancement of Vancomycin IN Everyday Patients (DEVINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01427842
Recruitment Status : Unknown
Verified August 2011 by Kathryn Daveson, The Canberra Hospital.
Recruitment status was:  Recruiting
First Posted : September 2, 2011
Last Update Posted : September 2, 2011
Sponsor:
Information provided by (Responsible Party):
Kathryn Daveson, The Canberra Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Vancomycin Therapy Drug: DEVINE vancomycin regimen Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : August 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Trough vancomycin concentration [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427842


Contacts
Layout table for location 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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kathryn Daveson, Bsc, MBBS, MPH The Canberra Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kathryn Daveson, Dr Kathryn Daveson, The Canberra Hospital
ClinicalTrials.gov Identifier: NCT01427842    
Other Study ID Numbers: ETH.4.11.076
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011
Keywords provided by Kathryn Daveson, The Canberra Hospital:
Trough concentration
Vancomycin
Pharmacokinetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents