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Bacteremia
Enrollment complete for Cubicin's phase III endocarditis/bacteremia trial
December 12th, 2004
Cubist Pharmaceuticals, Inc., (CBST), following consultation with the U.S. Food and Drug Administration (FDA), announced that it has completed enrollment of patients in its international phase III clinical trial of Cubicin (daptomycin for injection) for the treatment of infective endocarditis and bacteremia caused by Staphylococcus aureus. The FDA had previously requested that Cubist amend the original protocol to include patients with left-sided endocarditis. Based on the challenges of enrolling these seriously ill patients, the FDA has agreed that the inclusion of these patients would not be a requirement for a possible expansion of the CUBICIN label to include...
Source: Medical Letter on the CDC & FDA (2004-12-12)
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