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

NCT ID: NCT01995760

Last Updated: 2014-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Methicillin-resistant Staphylococcus Aureus Septicemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Jiuan Shen

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201310037RINA

Identifier Type: -

Identifier Source: org_study_id

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