NCT00862862

Evaluation of Vancomycin Treatment of Infections Due to Staphylococcus Aureus

Terminated Last updated 23 August 2023

What this trial tests

trial in Staphylococcus Aureus in 250 participants. Terminated before completion.

Timeline

1 April 2009

Primary endpoint
3 February 2011

3 February 2011

Quick facts

Lead sponsor	University of Nebraska
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	250
Start date	1 April 2009
Primary completion	3 February 2011
Estimated completion	3 February 2011
Sites	1 location across United States

Conditions studied

• Staphylococcus Aureus — all drugs for Staphylococcus Aureus →

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Staphylococcus Aureus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.