MRSANCT05395520
Vancomycin Monitoring: Is AUC Monitoring Appropriate for More Than Just Serious MRSA Infections?
An observational study of MRSA, run by Methodist Health System at 1 site in United States.
Trial summary
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- MRSA
- What is being tested?
- Retrospective chart review
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 8 Apr 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Adult patients who received vancomycin while inpatient at MCMC with at least one corresponding vancomycin trough level taken at steady state will be included.
Who may be able to join
- Patients hospitalized from June 2020- January 2021.
- 18 years and older
- At least 1 vancomycin trough concentration drawn at steady state
- Organism with an MIC of 2 mg/L, if vancomycin was continued and in whom a steady state trough concentration was obtained
Who cannot join
- Patients with end stage renal disease (on hemodialysis or peritoneal dialysis) or on continuous renal replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA) infections.1 Notable adverse effects of intravenous vancomycin include nephrotoxicity, ototoxicity and hypersensitivity reactions. Given its pharmacokinetic profile, therapeutic drug monitoring is essential in determining the therapeutic efficacy of vancomycin as well as for avoiding nephrotoxicity.
Read the detailed description
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA) infections.1 Notable adverse effects of intravenous vancomycin include nephrotoxicity, ototoxicity and hypersensitivity reactions. Given its pharmacokinetic profile, therapeutic drug monitoring is essential in determining the therapeutic efficacy of vancomycin as well as for avoiding nephrotoxicity.
The 2020 guidelines continue to enforce AUC/MIC as the preferred PK/PD parameter, but now recommend utilizing vancomycin peak and trough concentrations to target an AUC/MIC of 400-600 mg*h/L for serious MRSA infections. Although this AUC goal is not new, the 2009 consensus guidelines previously recommended trough only monitoring as a simplistic surrogate marker for attaining this AUC goal. Furthermore, the most accurate way of calculating AUC requires obtaining two steady state vancomycin serum concentrations over one dosing period. In this way, AUC guided monitoring requires more pharmacist and nursing time, the use of more hospital resources and additional cost to the patient.
As was true of the 2009 guidelines, the 2020 guidelines also leave certain questions unanswered. The paucity and conflicting data of vancomycin monitoring in patients with non-serious MRSA infections (skin and soft tissue infections, urinary tract infections, etc.), methicillin-sensitive Staphylococcus aureus (MSSA) infections and non-staphylococcal pathogen infections has left no guidance on the ideal vancomycin PK/PD targets in these patient populations. A literature search of AUC/MIC monitoring in patients with streptococcal and enterococcal infections yielded very few studies in patients with enterococcal infections and no studies in patients with streptococcal infections.
- Conditions
- MRSA
- Being tested
- Retrospective chart review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective chart reviewOther
Retrospective chart review to be conducted at Methodist Charlton Medical Center (MCMC) in Dallas, TX. Adult patients who received vancomycin while inpatient at MCMC with at least one corresponding vancomycin trough level taken at steady state will be included. All vancomycin orders by providers are entered as pharmacy to dose; thus dosing and routine monitoring is conducted by pharmacists.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of trough and AUC vancomycin monitoring
To compare the efficacy of targeting troughs of 10-20 mg/L vs targeting AUC of 400-600 for vancomycin monitoring without the use of vancomycin peak serum concentrations. o AUC will be calculated via the trapezoidal method.o Troughs will be stratified in the following categories: < 10 mg/L, 10-15 mg/L, 15-20 mg/L and > 20 mg/L.
Measured: up to 1 year
• Determine differences in efficacy/clinical outcome and re-admission rates of AUC monitoring compared to trough monitoring in severe or deep-seeded infections (pneumonia, endocarditis, osteomyelitis or bacteremia)
Readmission rate of AUC monitoring compared to trough monitoring. Re-admission within 30 days will be classified as due to previous infection or all-cause.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start8 Apr 2021
- Primary completion8 Apr 2024 (estimated)
- Study completion8 Apr 2024 (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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akins Ronda, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395520
- Sponsor's protocol ID
- 007.PHA.2021.C
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2022
- Last updated
- 10 Jul 2023
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin Monitoring: Is AUC Monitoring Appropriate for More Than Just Serious MRSA Infections?
- ClinicalTrials.gov ID
- NCT05395520
- Acronym / sponsor ID
- 007.PHA.2021.C
- Conditions
- MRSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 8 Apr 2024 (estimated)
- Study completion
- 8 Apr 2024 (estimated)
- First posted
- 27 May 2022 (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.
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA) infections.1 Notable adverse effects of intravenous vancomycin include nephrotoxicity, ototoxicity and hypersensitivity reactions. Given its pharmacokinetic profile, therapeutic drug monitoring is essential in determining the therapeutic efficacy of vancomycin as well as for avoiding nephrotoxicity.
Detailed description
Vancomycin, a glycopeptide antibiotic, is commonly prescribed as initial therapy for hospitalized patients due to its broad gram-positive coverage. Vancomycin is used for the treatment and prevention of a variety of bacterial infections ranging from streptococcal to methicillin-resistant Staphylococcus aureus (MRSA) infections.1 Notable adverse effects of intravenous vancomycin include nephrotoxicity, ototoxicity and hypersensitivity reactions. Given its pharmacokinetic profile, therapeutic drug monitoring is essential in determining the therapeutic efficacy of vancomycin as well as for avoiding nephrotoxicity.
The 2020 guidelines continue to enforce AUC/MIC as the preferred PK/PD parameter, but now recommend utilizing vancomycin peak and trough concentrations to target an AUC/MIC of 400-600 mg*h/L for serious MRSA infections. Although this AUC goal is not new, the 2009 consensus guidelines previously recommended trough only monitoring as a simplistic surrogate marker for attaining this AUC goal. Furthermore, the most accurate way of calculating AUC requires obtaining two steady state vancomycin serum concentrations over one dosing period. In this way, AUC guided monitoring requires more pharmacist and nursing time, the use of more hospital resources and additional cost to the patient.
As was true of the 2009 guidelines, the 2020 guidelines also leave certain questions unanswered. The paucity and conflicting data of vancomycin monitoring in patients with non-serious MRSA infections (skin and soft tissue infections, urinary tract infections, etc.), methicillin-sensitive Staphylococcus aureus (MSSA) infections and non-staphylococcal pathogen infections has left no guidance on the ideal vancomycin PK/PD targets in these patient populations. A literature search of AUC/MIC monitoring in patients with streptococcal and enterococcal infections yielded very few studies in patients with enterococcal infections and no studies in patients with streptococcal infections.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients who received vancomycin while inpatient at MCMC with at least one corresponding vancomycin trough level taken at steady state will be included.
Key inclusion criteria (4 listed)
- Patients hospitalized from June 2020- January 2021.
- 18 years and older
- At least 1 vancomycin trough concentration drawn at steady state
- Organism with an MIC of 2 mg/L, if vancomycin was continued and in whom a steady state trough concentration was obtained
Key exclusion criteria (1 listed)
- Patients with end stage renal disease (on hemodialysis or peritoneal dialysis) or on continuous renal replacement therapy
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 |
|---|---|---|
| Retrospective chart reviewRetrospective chart review to be conducted at Methodist Charlton Medical Center (MCMC) in Dallas, TX. Adult patients who received vancomycin while inpatient at MCMC with at least one corresponding vancomycin trough level taken at steady state will be included. All vancomycin orders by providers are entered as pharmacy to dose; thus dosing and routine monitoring is conducted by pharmacists. | Other | – |
Primary outcome
Efficacy of trough and AUC vancomycin monitoring
Time frame: up to 1 year
To compare the efficacy of targeting troughs of 10-20 mg/L vs targeting AUC of 400-600 for vancomycin monitoring without the use of vancomycin peak serum concentrations. o AUC will be calculated via the trapezoidal method.o Troughs will be stratified in the following categories: < 10 mg/L, 10-15 mg/L, 15-20 mg/L and > 20 mg/L.
• Determine differences in efficacy/clinical outcome and re-admission rates of AUC monitoring compared to trough monitoring in severe or deep-seeded infections (pneumonia, endocarditis, osteomyelitis or bacteremia)
Time frame: up to 1 year
Readmission rate of AUC monitoring compared to trough monitoring. Re-admission within 30 days will be classified as due to previous infection or all-cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- 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.
Akins Ronda, PharmD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRSA, run by Methodist Health System at 1 site in United States.
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 1 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 10 Jul 2023. 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 United States. 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?
Results are not available in the source record.
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?
Efficacy of trough and AUC vancomycin monitoring (time frame: up to 1 year). 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 Jul 2023.