Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections

Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections With Suspected or Confirmed Gram-Positive Bacterial Pathogens

This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.

• The patient or his/her legally authorized representative has given informed consent by means approved by the investigator's IRB/EC;
• > 18 years of age;
• Had one or more central venous catheters at the time initial signs of infection were evident;
• Creatinine clearance <50 mL/min;
• Bilirubin > 2x the upper limit of normal;
• Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation,
• Prolonged antibiotic therapy for CR-BSI anticipated (i.e., >2 weeks)