VancomycinVancoDATABayesNCT04756895
Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population
A study testing Vancomycin dose adjustment using the Bayesian method and Vancomycin dose adjustment using the trough level method in people with Vancomycin and Adult, run by CR-CSSS Champlain-Charles-Le Moyne at 1 site in Canada.
Trial summary
This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin, Adult, Area Under Curve
- What is being tested?
- Vancomycin dose adjustment using the Bayesian method and Vancomycin dose adjustment using the trough level method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 6 Aug 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age;
- Hospitalized patients
- Suspected or confirmed infection;
- Anticipated IV vancomycin treatment for 24 hours or more.
Who cannot join
- Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis);
- Treatment of vancomycin in continuous infusion;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vancomycin Dose Adjustments Comparing Trough Levels to The AUC0-24h/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population: A Pilot Study
This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated by the Bayesian approach rather than by a trough dosage. Randomization will be stratified according to infection severity. Approximately 60 subjects meeting all inclusion and no exclusion criteria will be randomized to have pharmacists perform vancomycin dose adjustments with AUC0-24h / MIC calculated by the Bayesian approach versus the trough dosage approach.
- Conditions
- Vancomycin, Adult, Area Under Curve
- Being tested
- Vancomycin dose adjustment using the Bayesian method, Vancomycin dose adjustment using the trough level method
- Keywords
- Bayesian approach, Dose adjustments, trough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin dose adjustment using the Bayesian methodOther
This intervention is the experimental method. The AUC/MIC target is 400-600 mg*hour/L.
Vancomycin dose adjustment using the trough level methodOther
This intervention is the standard method. Previous clinical guidelines recommended this method. The trough target is 10-15 mg/L for non-severe infections and 15-20 mg/L for severe infections.
| Study group | Role | What they receive |
|---|---|---|
| Bayesian method | Experimental | Pharmacists will perform vancomycin dose adjustments according to AUC0-24h/MIC using the Bayesian method with a web application Receives: Other: Vancomycin dose adjustment using the Bayesian method |
| Standard method | Active comparator | Pharmacists will perform vancomycin dose adjustments according to trough levels of vancomycin. Receives: Other: Vancomycin dose adjustment using the trough level method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of The Research Protocol
Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more
Measured: Through study completion, an average of 2 weeks
Evaluation of Recruitment
Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more
Measured: Baseline
Secondary outcomes (10)
The proportion of patients who reach a therapeutic level in the first 48 hours
Percentage of patients who reach a therapeutic level in the first 48 hours
Measured: At 48 hours after the first dose of vancomycin
Time to reach the vancomycin target
Number of hours necessary to reach the vancomycin target. Number of hours will be classified in the following categories: 24-48 hours, 49-96 hours, 97 hours and above.
Measured: During the vancomycin treatment
The number of adjustments required to reach the vancomycin target
Number of dose adjustments required to reach the vancomycin target
Measured: During the vancomycin treatment
The number of vancomycin dosage level monitoring to reach the vancomycin target
The number of vancomycin dosage level monitoring to reach the vancomycin target
Measured: During the vancomycin treatment
The proportion of vancomycin dosage level monitoring in the vancomycin target
Percentage of vancomycin dosage level monitoring in the vancomycin target
Measured: During the vancomycin treatment
The difference between the AUC calculated by the Bayesian method and the trapezoid method
Difference in percentage of the vancomycin AUC calculated by the Bayesian method and the trapezoid method
Measured: During the vancomycin treatment
The difference between the initial prescribed dose and the dose suggested by the Bayesian software.
Difference in percentage of the initial prescribed dose and the dose suggested by the Bayesian software.
Measured: Baseline
Proportion of acute kidney injury
Percentage of acute kidney injury.
Measured: During the vancomycin treatment
Average daily dose of vancomycin
Average of the daily dose of vancomycin calculated in mg per kg of total body weight
Measured: Through study completion, an average of 2 weeks
Operational Impact
Evaluation of the impact on pharmacist's time required for monitoring vancomycin
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Mar 2021
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VancomycinStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CR-CSSS Champlain-Charles-Le Moyne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benoit Crevier, CR-CSSS Champlain-Charles-Le Moyne
- Investigators
- Benoît Crevier, PharmD, MSc, Principal investigator, Charles-Le Moyne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756895
- Sponsor's protocol ID
- 2021-600
- Acronym
- VancoDATABayes
- Status last verified
- Sep 2021
- First submitted
- 8 Feb 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin Dose Adjustments Comparing Trough Levels to The AUC0-24h/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population: A Pilot Study
- ClinicalTrials.gov ID
- NCT04756895
- Acronym / sponsor ID
- VancoDATABayes / 2021-600
- Conditions
- Vancomycin, Adult, Area Under Curve
- Keywords
- Bayesian approach, Dose adjustments, trough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CR-CSSS Champlain-Charles-Le MoyneUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- 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.
This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated by the Bayesian approach rather than by a trough dosage. Randomization will be stratified according to infection severity. Approximately 60 subjects meeting all inclusion and no exclusion criteria will be randomized to have pharmacists perform vancomycin dose adjustments with AUC0-24h / MIC calculated by the Bayesian approach versus the trough dosage approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bayesian method | Experimental | Other: Vancomycin dose adjustment using the Bayesian methodPharmacists will perform vancomycin dose adjustments according to AUC0-24h/MIC using the Bayesian method with a web application |
| Standard method | Active comparator | Other: Vancomycin dose adjustment using the trough level methodPharmacists will perform vancomycin dose adjustments according to trough levels of vancomycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age;
- Hospitalized patients
- Suspected or confirmed infection;
- Anticipated IV vancomycin treatment for 24 hours or more.
Key exclusion criteria (2 listed)
- Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis);
- Treatment of vancomycin in continuous infusion;
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 |
|---|---|---|
| Vancomycin dose adjustment using the Bayesian methodThis intervention is the experimental method. The AUC/MIC target is 400-600 mg*hour/L. | Other | Bayesian method |
| Vancomycin dose adjustment using the trough level methodThis intervention is the standard method. Previous clinical guidelines recommended this method. The trough target is 10-15 mg/L for non-severe infections and 15-20 mg/L for severe infections. | Other | Standard method |
Primary outcome
Validation of The Research Protocol
Time frame: Through study completion, an average of 2 weeks
Evaluation of adhesion rate to the sampling protocol of 80% or more and adhesion rate to software recommendations of 90% or more
Evaluation of Recruitment
Time frame: Baseline
Evaluation of consent rate of 30% or more and the number of patients recruited per month of 10 or more
10 secondary outcomes
The proportion of patients who reach a therapeutic level in the first 48 hours
Time frame: At 48 hours after the first dose of vancomycin
Time to reach the vancomycin target
Time frame: During the vancomycin treatment
The number of adjustments required to reach the vancomycin target
Time frame: During the vancomycin treatment
The number of vancomycin dosage level monitoring to reach the vancomycin target
Time frame: During the vancomycin treatment
The proportion of vancomycin dosage level monitoring in the vancomycin target
Time frame: During the vancomycin treatment
The difference between the AUC calculated by the Bayesian method and the trapezoid method
Time frame: During the vancomycin treatment
The difference between the initial prescribed dose and the dose suggested by the Bayesian software.
Time frame: Baseline
Proportion of acute kidney injury
Time frame: During the vancomycin treatment
Average daily dose of vancomycin
Time frame: Through study completion, an average of 2 weeks
Operational Impact
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Benoît Crevier, PharmD, MSc principal investigator
Charles-Le Moyne Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin dose adjustment using the Bayesian method and Vancomycin dose adjustment using the trough level method in people with Vancomycin and Adult, run by CR-CSSS Champlain-Charles-Le Moyne at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 2021. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of The Research Protocol (time frame: Through study completion, an average of 2 weeks). The study lists 2 primary outcomes in all. 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 10 Sep 2021.