Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05395520 |
Other study ID # |
007.PHA.2021.C |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 8, 2021 |
Est. completion date |
April 8, 2024 |
Study information
Verified date |
July 2023 |
Source |
Methodist Health System |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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) 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.
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.