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

M

Methodist Health System

Status

Invitation-only

Conditions

MRSA

Treatments

Other: Retrospective chart review

Study type

Observational

Funder types

Other

Identifiers

NCT05395520
007.PHA.2021.C

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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