Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01427842




Trial ID
NCT01427842
Ethics application status
Date submitted
31/08/2011
Date registered
1/09/2011
Date last updated
1/09/2011

Titles & IDs
Public title
Dose Enhancement of Vancomycin IN Everyday Patients
Scientific title
A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin
Secondary ID [1] 0 0
ETH.4.11.076
Universal Trial Number (UTN)
Trial acronym
DEVINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vancomycin Therapy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DEVINE vancomycin regimen

Experimental: DEVINE vancomycin regimen - This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen.


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin

Eligibility
Key inclusion criteria
- All patients in general wards requiring routine treatment with vancomycin
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
The Canberra Hospital - Canberra
Recruitment postcode(s) [1] 0 0
2605 - Canberra

Funding & Sponsors
Primary sponsor type
Other
Name
The Canberra Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01427842
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kathryn Daveson, Bsc, MBBS, MPH
Address 0 0
The Canberra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathryn Daveson, BSc, MBBS, MPH
Address 0 0
Country 0 0
Phone 0 0
+61 2 6244 2222
Fax 0 0
Email 0 0
kdavesonwork@hotmail.com
Contact person for scientific queries