Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)
NCT ID: NCT00198302
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2005-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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Aurexis®
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Principal Investigators
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Seth Hetherington, M.D.
Role: STUDY_DIRECTOR
Inhibitex
Other Identifiers
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INH-AUR-002
Identifier Type: -
Identifier Source: org_study_id
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