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Treatment Phase Completed for Cubicin Endocarditis/Bacteremia Study
Due to the high mortality rate associated with endocarditis, blinded clinical data from patients enrolled in the study are provided to the DMC at pre-determined intervals to identify any safety-related issues. Patients with blood cultures positive for the presence of S. aureus were enrolled at sites in the U.S. and certain Western European countries. The study protocol includes patients with infective endocarditis and complicated or uncomplicated bacteremia. In the study, patients received either CUBICIN, at 6 mg/kg once daily, or the current standards of care, vancomycin in patients with confirmed methicillin-resistant S. aureus (MRSA) infection or a semi-synthetic penicillin if susceptible S. aureus is confirmed. Cubist continues to expect to report results from this trial in mid 2005.
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild or moderate in intensity and the most common were constipation, nausea, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.Cubicin.com.
Source: Cubist Pharmaceuticals