Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198302
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2005-09-09
Brief Title:
Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy Plus Aurexis or Placebo for Treatment of Staphylococcus Aureus Bacteremia SAB
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None