Dose Enhancement of Vancomycin IN Everyday Patients (DEVINE)
|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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427842
|Contact: Kathryn Daveson, BSc, MBBS, MPH||+61 2 6244 2222 ext firstname.lastname@example.org|
|Contact: Karlee Johnston, B. Pharm||+61 2 6244 2222 ext 42532||Karlee.Johnston@act.gov.au|
|Australia, Australian Capital Territory|
|The Canberra Hospital||Recruiting|
|Canberra, Australian Capital Territory, Australia, 2605|
|Contact: Kathryn Daveson, BSc, MBBS, MPH +612 62442222 ext 2105 email@example.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|
|Principal Investigator:||Kathryn Daveson, Bsc, MBBS, MPH||The Canberra Hospital|