Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
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ClinicalTrials.gov Identifier: NCT00057369
Recruitment Status : Unknown
Verified June 2003 by Vicuron Pharmaceuticals. Recruitment status was: Active, not recruiting
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 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
Study Start Date :
Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)