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Glycopeptide Antibiotic

Vancomycin Dosing for MRSA Infections (VIVID Trial)

N/A
Recruiting
Led By Anthony D Bai, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

VIVID Trial Summary

This trial will compare two vancomycin dosing strategies for treating MRSA infections. One strategy targets a trough level of 10 to 15mg/L, while the other targets an AUC/MIC of 400 to 600. The primary outcome will be treatment failure, which is a composite of mortality and microbiologic failure at 90 days. The trial will determine if targeting a trough level of 10 to 15mg/L is non-inferior to targeting an AUC/MIC of 400 to 600 in terms of treatment failure.

Who is the study for?
Adults with serious MRSA infections confirmed by culture, including blood, lung, brain, bone infections and more. They must join within 4 days of the culture test and can be new to vancomycin treatment or have had it for up to 4 days. Not eligible if they're on dialysis, expected to die within 48 hours, allergic to vancomycin or if their infection resists higher doses of vancomycin.Check my eligibility
What is being tested?
This study tests two ways of dosing vancomycin in treating serious MRSA infections: one targets drug levels in the blood (trough level) and the other focuses on how much drug stays in the body over time relative to the bacteria's resistance (AUC/MIC). It checks which method is just as good without being worse by more than a set margin.See study design
What are the potential side effects?
Vancomycin may cause kidney damage, hearing problems, low white blood cell counts leading to increased infection risk, allergic reactions like rashes or anaphylaxis (severe), infusion-related reactions such as redness or pain at injection site.

VIVID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a serious MRSA infection confirmed by lab tests.

VIVID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment failure
Secondary outcome measures
Day 3 AUC
Major adverse kidney events
Renal replacement therapy
+3 more

VIVID Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vancomycin targeting trough of 10 to 15mg/LExperimental Treatment1 Intervention
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.
Group II: Vancomycin targeting AUC of 400 to 600Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,301 Total Patients Enrolled
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,186 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
26,055 Total Patients Enrolled

Media Library

Staphylococcus aureus Research Study Groups: Vancomycin targeting trough of 10 to 15mg/L, Vancomycin targeting AUC of 400 to 600
Staphylococcus aureus Clinical Trial 2023: Vancomycin Highlights & Side Effects. Trial Name: NCT04793152 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What clinical conditions is Vancomycin typically employed to treat?

"Vancomycin has proven to be an effective remedy for a variety of staphylococcal infections, including enterocolitis caused by Staphylococcus aureus."

Answered by AI

How many individuals have willingly participated in this research?

"Unfortunately, this clinical trial is not in need of any more volunteers at the moment. It was first posted on January 1st 2021 and its most recent update occured on May 16th 2022. If you are looking for a study to join, there are currently 774 trials recruiting participants with mrsa and 55 studies accepting patients for Vancomycin therapy."

Answered by AI

Is recruitment currently underway for this experiment?

"The information on clinicaltrials.gov alludes to the fact that this investigation is no longer accepting participants, since it was initially posted in January 2023 and last updated in May 2022. Nevertheless, there are presently 829 other medical trials enrolling patients at the present time."

Answered by AI

Are there any existing studies that involve Vancomycin as a key element?

"Presently, there are 55 ongoing clinical trials for Vancomycin and 6 of those studies have reached Phase 3. While the majority of these investigations occur in Jupiter, Florida; globally 315 different locations house research into this antibiotic."

Answered by AI

Who else is applying?

What site did they apply to?
Hamilton Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC
2023. "Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04793152.
All > Rsv > Mrsa
~424 spots leftby Jan 2026
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