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

• Status: Unknown status
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vicuron Pharmaceuticals
• Treatments: Dalbavancin; Teicoplanin; Vancomycin

Criteria

• 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)