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Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main objective of this study will be to test the safety and behavior of Altastaph in patients with S.aureus bacteremia and continuing fever
Staphylococcus aureus has been recognized as an important community - acquired and nosocomial pathogen. Because it is a common cause of osteomyelitis, endocarditis, and meningitis, S. aureus infections lead to considerable morbidity and mortality. The main objective of this study will be to test the safety and pharmacokinetics of Altastaph in patients with S. aureus bacteremia and persistent fever. This study will also assess the efficacy of Altastaph versus control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| altastaph | Experimental | S. aureus Immune Globulin Intravenous (Human) 5% |
|
| Placebo | Placebo Comparator | 0.45% Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S. aureus Immune Globulin Intravenous (Human) 5% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics | 6 weeks | |
| Efficacy | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17893153 | Derived | Rupp ME, Holley HP Jr, Lutz J, Dicpinigaitis PV, Woods CW, Levine DP, Veney N, Fowler VG Jr. Phase II, randomized, multicenter, double-blind, placebo-controlled trial of a polyclonal anti-Staphylococcus aureus capsular polysaccharide immune globulin in treatment of Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2007 Dec;51(12):4249-54. doi: 10.1128/AAC.00570-07. Epub 2007 Sep 24. |
| Label | URL |
|---|---|
| Nabi Biopharmaceuticals | View source |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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