Evaluation of Vancomycin Treatment of Infections Due to Staphylococcus Aureus

NCT00862862 | Terminated

• 1 other identifier: 0002-09-FB
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Staphylococcus Aureus

Keywords

infection; staphylococcus aureus; vancomycin; pharmacodynammics

Outcome Measures

Primary Outcomes (1)

• Percentage of vancomycin dosing regimens achieving AUC:MIC ratio > 400

  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.

  12 months

Secondary Outcomes (1)

• Therapeutic vancomycin threshold

  12 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected or documentd staphylcoccus aureus infection and prescribed vancomycin

You may qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Keith M Olsen, PharmD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 17, 2009
• Study Start: April 1, 2009
• Primary Completion: February 3, 2011
• Study Completion: February 3, 2011
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

US (1)