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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)?

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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

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.

Condition or disease
Methicillin-resistant Staphylococcus Aureus Septicemia

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.


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Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: Day 30 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture) ]

Secondary Outcome Measures :
  1. 90-day mortality [ Time Frame: Day 90 after index date (the date of positive methicillin-resistant Staphylococcus aureus blood culture) ]
  2. In-hospital mortality [ Time Frame: Discharge day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995760


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Li-Jiuan Shen National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01995760     History of Changes
Other Study ID Numbers: 201310037RINA
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Keywords provided by National Taiwan University Hospital:
vancomycin
therapeutic response monitoring
AUC/MIC
Additional relevant MeSH terms:
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Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents