Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
This trial is active, not recruiting.
|Start date||February 2001|
|End date||June 2003|
|Trial size||88 participants|
|Trial identifier||NCT00057369, VER001-4|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Male or female participants at least 18 years old.
- 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)
|Official title||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|
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