The trial compared Zyvox to vancomycin, oxacillin, or dicloxacillin (comparator antibiotics) in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. In this study, patients treated with Zyvox had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection.
Patients with Gram positive infections had no difference in mortality according to their antibiotic treatment. In contrast, mortality was higher in patients treated with Zyvox who were infected with Gram negative organisms alone, with both Gram positive and Gram negative organisms, or who had no infection when they entered the study.
Zyvox is not approved for the treatment of catheter-related bloodstream infections, catheter-site infections, or for the treatment of infections caused by Gram negative bacteria. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately. The FDA said that it is currently evaluating the new study along with other information about Zyvox.