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Trial record 1 of 7662 for:    Area Under Curve
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The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995760
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date November 10, 2013
First Posted Date November 27, 2013
Last Update Posted Date September 4, 2014
Study Start Date November 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2013)
30-day mortality [ Time Frame: Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01995760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 26, 2013)
  • 90-day mortality [ Time Frame: Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture) ]
  • In-hospital mortality [ Time Frame: Discharge day ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
Official Title The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients of National Taiwan University Hospital. During the period of 2001/1/1 to 2013/12/31, age above or equal to 20 year-old adult with positive methicillin-resistant Staphylococcus aureus blood culture who receiving vancomycin therapy with therapeutic monitoring.
Condition Methicillin-resistant Staphylococcus Aureus Septicemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 2, 2014)
123
Original Estimated Enrollment
 (submitted: November 26, 2013)
1500
Actual Study Completion Date June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01995760
Other Study ID Numbers 201310037RINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Li-Jiuan Shen National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date September 2014