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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 A

Brief 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.


Detailed Summary:
Sponsor: Bristol-Myers Squibb

Current Primary Outcome:

  • • To evaluate the safety of standard of care, plus a single dose of Aurexis® compared to a single dose of placebo, in subjects with documented SAB
  • • To evaluate the pharmacokinetics of a single dose of Aurexis® in combination with standard of care in the subjects with SAB
  • • To evaluate the activity of a single dose of Aurexis® in combination with standard of care, as measured by:
  • o number of subjects with uncomplicated SAB at baseline who progress to complicated SAB
  • o number of subjects with microbiologically documented relapse of SAB
  • o mortality rates


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • • To evaluate the effect of a single dose of Aurexis® in combination with standard of care on the:
  • o proportion of subjects who develop sepsis, severe sepsis, or septic shock
  • o time to achieve a negative blood culture
  • o time to defervescence
  • o mean (and median) number of days in the hospital and ICU
  • o mean (and median) number of days requiring mechanical ventilation


Original Secondary Outcome: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: September 9, 2005
Date Started:
Date Completion: February 2005
Last Updated: March 28, 2013
Last Verified: March 2013