MRSATAUCNCT04793152
Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC
A study testing Vancomycin in people with MRSA, run by Anthony Bai at 4 sites in Canada.
Trial summary
Intravenous vancomycin is considered first line therapy for serious methicillin-resistant Staphylococcus aureus (MRSA) infections including bacteremia, central nervous system infection, pneumonia, pleural space infection, bone or joint infection, prosthetic joint infection and deep abscesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 4 sitesCanada
- Study dates
- 20 Mar 2023to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients with serious MRSA infections based on culture results including bacteremia, pneumonia, pleural space infection, central nervous system infection, bone infection, septic arthritis, prosthetic joint infection, and deep abscess
- Enrolment within 4 days from date of MRSA culture collection
- Patient either currently not on vancomycin or has received vancomycin for 4 days or less
Who cannot join
- Vancomycin minimum inhibitory concentration (MIC) ≥2ug/mL
- Patient is palliative or expected to die in the next 48 hours, or requires critical care resources but will not receive it due to advanced care directives
- History of type 1 hypersensitivity reaction to vancomycin
- Patients on intermittent hemodialysis or peritoneal dialysis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Mark Loeb, MD, 905-525-9140 ext. 26679, loebm@mcmaster.ca
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Zain Chagla, MD, 905-525-9140 ext. 33998, chaglaz@mcmaster.ca
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Anthony D Bai, MD, 613-533-6000 ext. 75471, tony.bai@queensu.ca
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3H 2R9
Todd Lee, MD, (514) 934-1934 ext. 23730, todd.lee@mcgill.ca
About this study
Intravenous vancomycin is considered first line therapy for serious methicillin-resistant Staphylococcus aureus (MRSA) infections including bacteremia, central nervous system infection, pneumonia, pleural space infection, bone or joint infection, prosthetic joint infection and deep abscesses. The effectiveness and toxicity of vancomycin depend on its dosing and chosen target. The most recent guidelines suggest targeting area under the curve over 24 hours over minimum inhibitory concentration (AUC/MIC) of 400 to 600. Implementation of AUC/MIC requires Bayesian software that can be variable, costly, complicated and time consuming. Ideally, AUC/MIC dosing would also require susceptibility testing by broth microdilution, which is not commonly done. It is recommended to target AUC of 400 to 600 assuming a MIC of 1ug/mL when MIC by broth microdilution is not known. Targeting a trough level of 10 to 15mg/L may be a reasonable and more practical alternative without compromising effectiveness. We will be conducting a randomized controlled non-inferiority trial to compare intravenous vancomycin dosing strategy targeting a trough level of 10 to 15mg/L versus AUC of 400 to 600 assuming a MIC of 1ug/mL by broth microdilution for serious MRSA infections. The primary outcome will be treatment failure, which is a composite of mortality and microbiologic failure at 90 days. We hypothesize that targeting a trough level of 10 to 15mg/L is non-inferior to targeting a AUC of 400 to 600 in terms of treatment failure. The criterion for non-inferiority is that a two-sided 95% confidence interval for difference in risk of treatment failure will lie within the non-inferiority margin of 10%.
- Conditions
- MRSA
- Being tested
- Vancomycin
- Keywords
- vancomycin, MRSA, trough, AUC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Administration as outlined
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin targeting trough of 10 to 15mg/L | Experimental | If the patient has not received intravenous vancomycin yet, a loading dose of 25mg/kg (maximum 2g) will be given if the patient is severely ill at the discretion of the physician and pharmacist. The initial dose is 15mg/kg with a maximum dose of 2g. The frequency would be based on creatinine clearance (CrCl) as per the Cockcroft-Gault equation: Q8H if CrCl is >100mL/min, Q12H if CrCl is 50-100mL/min, Q24H if CrCl is 30- 49mL/min, and Q48H if CrCl is <30mL/min. Pharmacists can change the initial dose at their own discretion.
Trough level will be done 30 minutes before the 4th dose. For Q48H dosing, a trough level will be done before the second dose. Vancomycin dosing will be adjusted to target trough level of 10 to 15mg/L. If not at target, the pharmacist will adjust the dose based on an assumption of linear pharmacokinetics. Trough will be remeasured before the fourth dose of the new regimen. Receives: Drug: Vancomycin |
| Vancomycin targeting AUC of 400 to 600 | Active comparator | The initial intravenous vancomycin dosing is the same as described above for the trough group.
The AUC target will be 400 to 600, which assumes a MIC of 1ug/mL by broth microdilution.
After the first non-loading dose of vancomycin, patients will have vancomycin level 30 minutes before the next dose. As per the pharmacist's discretion, patient may have an additional vancomycin level one hour after infusion of vancomycin for more accurate estimates. A pharmacist will use a Bayesian software to estimate the AUC and the optimal dose. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Treatment failure is defined as death due to any cause or microbiologic failure based on demonstration of MRSA on repeated culture from the original site or another sterile site more than 1 week from randomization. Treatment failure will be determined by an independent committee of physicians after reviewing the clinical, laboratory and microbiologic data.
Measured: 90 days
Secondary outcomes (6)
Major adverse kidney events
New and persistent renal-replacement therapy, or serum creatinine that is 200% or more than the baseline value during the follow-up period
Measured: 90 days
Vancomycin associated nephrotoxicity
Increase in serum creatinine by ≥26.4mmol/L or ≥50% since starting vancomycin when compared to baseline
Measured: 90 days
Renal replacement therapy
Need for initiation of renal replacement therapy at any time during follow-up
Measured: 90 days
Time to target
Time in days to reach target level (trough of 10 to 15mg/L in the intervention group and AUC/MIC of 400 to 600 in the comparison group)
Measured: 90 days
Day 3 AUC
AUC as calculated using Bayesian modeling on day 3 from randomization
Measured: 3 days
Vancomycin cost
Direct cost of vancomycin monitoring and dosing from perspective of hospital system
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start20 Mar 2023
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSAStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anthony Bai
- Sponsor type
- University, hospital or other
- Collaborators
- Physician Services Incorporated, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Anthony Bai, Queen's University
- Investigators
- Anthony D Bai, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793152
- Sponsor's protocol ID
- 13327
- Acronym
- TAUC
- Status last verified
- Jan 2026
- First submitted
- 8 Mar 2021
- Last updated
- 23 Jan 2026
- Results posted
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC
- ClinicalTrials.gov ID
- NCT04793152
- Acronym / sponsor ID
- TAUC / 13327
- Conditions
- MRSA
- Keywords
- vancomycin, MRSA, trough, AUC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Anthony BaiUniversity, hospital or other
- Collaborators
- Physician Services Incorporated, Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 11 Mar 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.
Intravenous vancomycin is considered first line therapy for serious methicillin-resistant Staphylococcus aureus (MRSA) infections including bacteremia, central nervous system infection, pneumonia, pleural space infection, bone or joint infection, prosthetic joint infection and deep abscesses. The effectiveness and toxicity of vancomycin depend on its dosing and chosen target. The most recent guidelines suggest targeting area under the curve over 24 hours over minimum inhibitory concentration (AUC/MIC) of 400 to 600. Implementation of AUC/MIC requires Bayesian software that can be variable, costly, complicated and time consuming. Ideally, AUC/MIC dosing would also require susceptibility testing by broth microdilution, which is not commonly done. It is recommended to target AUC of 400 to 600 assuming a MIC of 1ug/mL when MIC by broth microdilution is not known. Targeting a trough level of 10 to 15mg/L may be a reasonable and more practical alternative without compromising effectiveness. We will be conducting a randomized controlled non-inferiority trial to compare intravenous vancomycin dosing strategy targeting a trough level of 10 to 15mg/L versus AUC of 400 to 600 assuming a MIC of 1ug/mL by broth microdilution for serious MRSA infections. The primary outcome will be treatment failure, which is a composite of mortality and microbiologic failure at 90 days. We hypothesize that targeting a trough level of 10 to 15mg/L is non-inferior to targeting a AUC of 400 to 600 in terms of treatment failure. The criterion for non-inferiority is that a two-sided 95% confidence interval for difference in risk of treatment failure will lie within the non-inferiority margin of 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin targeting trough of 10 to 15mg/L | Experimental | Drug: VancomycinIf the patient has not received intravenous vancomycin yet, a loading dose of 25mg/kg (maximum 2g) will be given if the patient is severely ill at the discretion of the physician and pharmacist. The initial dose is 15mg/kg with a maximum dose of 2g. The frequency would be based on creatinine clearance (CrCl) as per the Cockcroft-Gault equation: Q8H if CrCl is >100mL/min, Q12H if CrCl is 50-100mL/min, Q24H if CrCl is 30- 49mL/min, and Q48H if CrCl is <30mL/min. Pharmacists can change the initial dose at their own discretion. Trough level will be done 30 minutes before the 4th dose. For Q48H dosing, a trough level will be done before the second dose. Vancomycin dosing will be adjusted to target trough level of 10 to 15mg/L. If not at target, the pharmacist will adjust the dose based on an assumption of linear pharmacokinetics. Trough will be remeasured before the fourth dose of the new regimen. |
| Vancomycin targeting AUC of 400 to 600 | Active comparator | Drug: VancomycinThe initial intravenous vancomycin dosing is the same as described above for the trough group. The AUC target will be 400 to 600, which assumes a MIC of 1ug/mL by broth microdilution. After the first non-loading dose of vancomycin, patients will have vancomycin level 30 minutes before the next dose. As per the pharmacist's discretion, patient may have an additional vancomycin level one hour after infusion of vancomycin for more accurate estimates. A pharmacist will use a Bayesian software to estimate the AUC and the optimal dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with serious MRSA infections based on culture results including bacteremia, pneumonia, pleural space infection, central nervous system infection, bone infection, septic arthritis, prosthetic joint infection, and deep abscess
- Enrolment within 4 days from date of MRSA culture collection
- Patient either currently not on vancomycin or has received vancomycin for 4 days or less
Key exclusion criteria (4 listed)
- Vancomycin minimum inhibitory concentration (MIC) ≥2ug/mL
- Patient is palliative or expected to die in the next 48 hours, or requires critical care resources but will not receive it due to advanced care directives
- History of type 1 hypersensitivity reaction to vancomycin
- Patients on intermittent hemodialysis or peritoneal dialysis
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 |
|---|---|---|
| VancomycinAdministration as outlined | Drug | Vancomycin targeting AUC of 400 to 600, Vancomycin targeting trough of 10 to 15mg/L |
Primary outcome
Treatment failure
Time frame: 90 days
Treatment failure is defined as death due to any cause or microbiologic failure based on demonstration of MRSA on repeated culture from the original site or another sterile site more than 1 week from randomization. Treatment failure will be determined by an independent committee of physicians after reviewing the clinical, laboratory and microbiologic data.
6 secondary outcomes
Major adverse kidney events
Time frame: 90 days
Vancomycin associated nephrotoxicity
Time frame: 90 days
Renal replacement therapy
Time frame: 90 days
Time to target
Time frame: 90 days
Day 3 AUC
Time frame: 3 days
Vancomycin cost
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for MRSA
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Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
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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.
Anthony D Bai, MD principal investigator
Queen's University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin in people with MRSA, run by Anthony Bai at 4 sites 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony D Bai, MD (613-533-6000 ext. 75471, tony.bai@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 90 days). 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 23 Jan 2026.