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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aurexis® | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| • 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 |
| Measure | Description | Time Frame |
|---|---|---|
| • 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Hetherington, M.D. | Inhibitex | Study Director |
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| 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 |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D016470 | Bacteremia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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