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

Methicillin-resistant Staphylococcus Aureus Septicemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995760
• Other study ID #: 201310037RINA
• Status: Completed
• Phase: N/A
• First received: November 10, 2013
• Last updated: September 2, 2014
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus Septicemia
• Staphylococcal Infections

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality		Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)	No
Secondary	90-day mortality		Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture)	No
Secondary	In-hospital mortality		Discharge day	No