Vancomycin TherapyPhase 2DEVINENCT01427842
Dose Enhancement of Vancomycin IN Everyday Patients
A Phase 2 study testing DEVINE vancomycin regimen in people with Vancomycin Therapy, run by The Canberra Hospital at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vancomycin Therapy
- What is being tested?
- DEVINE vancomycin regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients in general wards requiring routine treatment with vancomycin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The Canberra Hospital
Canberra, Australian Capital Territory, 2605
Kathryn Daveson, BSc, MBBS, MPH, +612 62442222 ext. 2105, kdavesonwork@hotmail.com
Karlee Johnston, B. Pharm, +612 6244 2222 ext. 42532, Karlee.Johnston@act.gov.au
About this study
Official title: 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.
Read the 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
- Conditions
- Vancomycin Therapy
- Being tested
- DEVINE vancomycin regimen
- Keywords
- Trough concentration, Vancomycin, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEVINE vancomycin regimenDrug
Also called Pharmacokinetically derived vancomycin dosing regimen, Pharmacokinetic 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.
| Study group | Role | What they receive |
|---|---|---|
| DEVINE vancomycin regimen | Experimental | This is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen. Receives: Drug: DEVINE vancomycin regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vancomycin TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Canberra Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Daveson, The Canberra Hospital
- Investigators
- Kathryn Daveson, Bsc, MBBS, MPH, Principal investigator, The Canberra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427842
- Sponsor's protocol ID
- ETH.4.11.076
- Acronym
- DEVINE
- Status last verified
- Aug 2011
- First submitted
- 31 Aug 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centred Randomised Trial of a New Vancomycin Dosing Method Compared to Standard Care in Everyday Patients Receiving Vancomycin
- ClinicalTrials.gov ID
- NCT01427842
- Acronym / sponsor ID
- DEVINE / ETH.4.11.076
- Conditions
- Vancomycin Therapy
- Keywords
- Trough concentration, Vancomycin, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Canberra HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEVINE vancomycin regimen | Experimental | Drug: DEVINE vancomycin regimenThis is the intervention arm and will be the pharmacokinetically derived vancomycin dosing regimen. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in general wards requiring routine treatment with vancomycin
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEVINE vancomycin regimenAlso: Pharmacokinetically derived vancomycin dosing regimen, Pharmacokinetic vancomycin regimenThe 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. | Drug | DEVINE vancomycin regimen |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Daveson, Bsc, MBBS, MPH principal investigator
The Canberra Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DEVINE vancomycin regimen in people with Vancomycin Therapy, run by The Canberra Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Daveson, BSc, MBBS, MPH (+61 2 6244 2222 ext. 42105, kdavesonwork@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough vancomycin concentration (time frame: At steady state for vancomycin received between 36 and 60 hours after the initial dose of vancomycin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.