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

NCT05395520 | Unknown

• 1 other identifier: 007.PHA.2021.C
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 1 year

Interventions

Retrospective chart review OTHER

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients hospitalized from June 2020- January 2021.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

• Akins Ronda, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 27, 2022
• Study Start: April 8, 2021
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)