The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01995760

Enrollment

123

Registered

2013-11-27

Start date

2013-11-30

Completion date

2014-06-30

Last updated

2014-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-resistant Staphylococcus Aureus Septicemia

Keywords

vancomycin, therapeutic response monitoring, AUC/MIC

Brief summary

The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.

Detailed description

Several studies have shown AUC/MIC to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. However, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. In 2011, Patel et al showed that highly difference between AUC(72-96h) and Cmin(96h). Different dosing and creatinine clearance may reach the same trough drug level with different AUC. The investigators wonder whether trough drug level can serve as a substitute marker for AUC and as a parameter for vancomycin therapeutic monitoring. In this study, the investigators will calculate AUC/MIC of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inpatients of National Taiwan University Hospital * Age above or equal to 20 years old * Positive methicillin-resistant Staphylococcus aureus blood culture * Receiving vancomycin therapy for definitive use * Undergoing therapeutic drug monitoring (had serum vancomycin concentration level)

Exclusion criteria

* Age below 20 years old * Without details of vancomycin dose and frequency * Vancomycin treatment shorter than 72 hours * Without renal function data (serum creatinine level, creatinine clearance) * Without infection-related clinical outcomes (lab data such as white blood cell count , seg, C reactive protein , body temperature records) * Receiving renal replacement therapy * Therapeutic drug monitoring before reaching steady state * With abnormal and undefined serum concentration

Design outcomes

Primary

Measure	Time frame
30-day mortality	Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)

Secondary

Measure	Time frame
90-day mortality	Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)
In-hospital mortality	Discharge day

Countries

Taiwan

Outcome results