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Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)

Staphylococcus Aureus Bacteremia Clinical Trial

Official title:
A Phase II, Randomized, Double-blind, Multi-center Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)

Clinical Trial Summary

Hospitalized patients at least 18 years of age, with Staphylococcus aureus bacteremia (SAB) will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.

The purpose of this study is to assess the safety and pharmacokinetics of standard antibiotic therapy, plus Aurexis or Placebo for treatment of (SAB). Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00198302
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 2
Completion date February 2005
View Details
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