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

Completed

• Conditions: Methicillin-resistant Staphylococcus Aureus Septicemia

• Registration Number: NCT01995760
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-10
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-11-27
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-02
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan