Bacteremia Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Open-Label, Comparative Study to Assess the Safety and Efficacy of Daptomycin Compared to Conventional Therapy In the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to Staph Aureus
The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).
Even with prompt treatment, Staphylococcus aureus Infective Endocarditis (IE) continues to
be associated with significant morbidity and mortality indicating a need for new therapeutic
approaches. In vitro, daptomycin is rapidly bactericidal, with concentration-dependent
killing, and MIC90 of 0.5 microgram/ml for S. aureus; in clinical studies, daptomycin
appears to be well tolerated and can be administered once every 24 hours by i.v. infusion.
These characteristics suggest it should be clinically and microbiologically effective in the
treatment of serious S. aureus infections, including IE and bacteremia
Comparison: standard of care (Vancomycin or Semi-synthetic Penicillin with adjunct
gentamicin)
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