Evaluation of Vancomycin Treatment of Infections Due to Staphylococcus Aureus

Stopped early

Conditions studied: Staphylococcus Aureus

In brief

Objective: The objective of the study is to evaluate the ability of current vancomycin dosing strategies to attain the pharmacodynamic target of an area under the curve (AUC) to minimum inhibitory concentration (MIC) ratio greater than 400:1 for patients with a suspected or documented Staphylococcus aureus infection. Primary Outcome: The primary outcome is the percentage of vancomycin dosing regimens that achieve AUC:MIC ratio \> 400 on the first occurrence of vancomycin use in patients with a suspected or documented S. aureus infection at The Nebraska Medical Center. Secondary Outcomes: 1. To assess the probability that vancomycin AUC:MIC ratios obtained from The Nebraska Medical Center patients exceed a therapeutic threshold using S. aureus MICs from isolates obtained from The Nebraska Medical Center. 2. Using MIC data from the TRUST Study database (large national surveillance database) and the vancomycin AUC data obtained from TNMC patients, perform a Monte Carlo analysis that will assess the probability of achieving a therapeutic vancomycin threshold with a large number of isolates.

Key facts

Study ID

NCT00862862

Run by

University of Nebraska

People needed

250

Starts

2009-04-01

Expected to finish

2011-02-03

Last updated by the study team

2023-08-23

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 19 years of age or older
• Admitted to an inpatient care unit at The Nebraska Medical Center
• Prescribed intravenous vancomycin therapy with a dosing interval of 24 hours or less
• Vancomycin therapy that lasts for at least 3 doses or 5 half-lives as scheduled with no dosage changes

You may not qualify if…

• Estimated creatinine clearance (CrCl) less than 30 ml/min using the Cockroft-Gault equation (in patients over the age of 65 a SCr of 1.0 mg/dL will be assumed for all patients with a reported SCr less than 1.0 mg/dL). Ideal body weight will be used for the Cockroft-Gault equation unless the actual body weight is less than the ideal body weight.
• Patients requiring any form of dialysis
• Pregnancy

Where it is running

• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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