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)