Vancomycin Monitoring

Sponsor

Methodist Health System (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05395520

Collaborator

(none)

146

Enrollment

Location

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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) 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.

Condition or Disease	Intervention/Treatment	Phase
MRSA	Other: Retrospective chart review

Detailed Description

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

Study Type:

Observational

Anticipated Enrollment :

146 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Vancomycin Monitoring: Is AUC Monitoring Appropriate for More Than Just Serious MRSA Infections?

Actual Study Start Date :

Apr 8, 2021

Anticipated Primary Completion Date :

Apr 8, 2023

Anticipated Study Completion Date :

Apr 8, 2023

Outcome Measures

Primary Outcome Measures

Efficacy of trough and AUC vancomycin monitoring [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

Patients with end stage renal disease (on hemodialysis or peritoneal dialysis) or on continuous renal replacement therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

Methodist Health System

Investigators

Principal Investigator: Akins Ronda, PharmD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT05395520

Other Study ID Numbers:

007.PHA.2021.C

First Posted:

May 27, 2022

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 27, 2022