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



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

For Condition: Bacteremia
Status: Recruiting
Sponsor(s): Vicuron Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment: 88

Location and Contact Information:

Wellstar/Kennestone Hospital *Recruiting*
Marietta,  Georgia,  30060
United States
Recruiting  


Additional Information:
Study ID Numbers:
  VER001-4; 
Study Start Date: February 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057369

Other Bacteremia Studies:
1. Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections

2. Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-related Bloodstream Infections

3. Tigecycline for the Treatment of Subjects with Selected Serious Infections Due to Resistant Gram-Negative Organisms

4. Antibiotic treatment for patients with infections of short term in-dwelling vascular catheters due to a specific bacteria (gram positive bacteria)

5. Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

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

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