Comparing vancomycin dosing methods for serious MRSA infections
Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC
NA · Queen's University · NCT04793152
This study tests if a simpler way of giving vancomycin can work just as well as a more complicated method for adults with serious MRSA infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University (other) |
| Locations | 4 sites (Hamilton, Ontario and 3 other locations) |
| Trial ID | NCT04793152 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different dosing strategies for intravenous vancomycin in treating serious methicillin-resistant Staphylococcus aureus (MRSA) infections. It compares the traditional trough level approach with a newer method that targets the area under the curve over 24 hours relative to the minimum inhibitory concentration (AUC/MIC). The study aims to determine if the simpler trough level dosing can be as effective as the more complex AUC/MIC method without compromising patient outcomes. Eligible participants include adults with serious MRSA infections who have not been on vancomycin for more than four days.
Who should consider this trial
Good fit: Ideal candidates are adults with serious MRSA infections who have not received vancomycin for more than four days.
Not a fit: Patients with a vancomycin MIC of 2ug/mL or higher, or those who are palliative or critically ill, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could simplify vancomycin dosing for MRSA infections, making treatment more accessible and efficient for patients.
How similar studies have performed: Other studies have explored vancomycin dosing strategies, but this specific comparison of trough versus AUC/MIC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hamilton, Ontario and 3 other locations
- Hamilton Health Sciences — Hamilton, Ontario, Canada (RECRUITING)
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (RECRUITING)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (RECRUITING)
- McGill University Health Centre — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Anthony D Bai, MD — Queen's University
- Study coordinator: Anthony D Bai, MD
- Email: tony.bai@queensu.ca
- Phone: 613-533-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MRSA, vancomycin, trough, AUC