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

Tracking Information
First Received Date ^ICMJE	March 31, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	February 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
Official Title ^ICMJE	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
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bacteremia
Intervention ^ICMJE	Drug: dalbavancin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	88
Completion Date	June 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00057369
Responsible Party
Study ID Numbers ^ICMJE	VER001-4
Study Sponsor ^ICMJE	Vicuron Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Vicuron Pharmaceuticals
Verification Date	June 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP