Phase II, Randomized, Double-Blind, Multicenter Study Comparing the Safety and Pharmacokinetics of Tefibazumab to Placebo for Treatment of Staphylococcus aureus Bacteremia
| Autor: | Michele Texter, James P. Steinberg, Eric Wenzel, G. Ralph Corey, Lisa G. Winston, John W. Baddley, Thomas Moore, J. John Weems, Priya Sampathkumar, Violet A. Kelley, Christine J. Kubin, Joseph Patti, Vance G. Fowler, Scott G. Filler, Rohit Talwani, Joseph F. John, Seth Hetherington |
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| Jazyk: | angličtina |
| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Staphylococcus aureus Randomization Bacteremia Clinical Therapeutics Placebo Pharmacokinetics Double-Blind Method Tefibazumab Internal medicine medicine Humans Pharmacology (medical) Dosing Adverse effect Aged Pharmacology business.industry Antibodies Monoclonal Middle Aged Staphylococcal Infections medicine.disease Clumping factor A Surgery Infectious Diseases Area Under Curve Female business medicine.drug |
| Popis: | Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were |
| Databáze: | OpenAIRE |
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