Status:
COMPLETED
Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Staphylococcus Aureus Bacteremia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 f...
Eligibility Criteria
Inclusion
- Male or female, age ≥ 18 years old
- Informed consent obtained from subject or legal guardian
- Willing to practice reliable birth control measures during the study period
- Diagnosis of SAB, as evidenced by clinical symptoms and one positive blood culture obtained ≤ 72 hours prior to initiation of study drug infusion
Exclusion
- Pregnant or nursing females
- Polymicrobial bacteremia
- Diagnosis of septic shock (refer to APPENDIX B)
- Neutropenia (absolute neutrophil count \< 500/mm³)
- Undergoing any type of dialysis or expected to start dialysis within 30 days
- Moribund clinical condition with a high likelihood of death within 72 hours of randomization
- Received an investigational drug within 30 days of study entry
- Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00198302
End Date
February 1 2005
Last Update
March 29 2013
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