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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00057369
Recruitment Status : Unknown
Verified June 2003 by Vicuron Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2003
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Vicuron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 31, 2003
First Posted Date  ICMJE April 2, 2003
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE February 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacteremia
Intervention  ICMJE Drug: dalbavancin
Study Arms  ICMJE Not Provided
Publications * Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2021 Dec 14. doi: 10.1007/s40121-021-00568-7. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
88
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2003
Primary Completion Date Not Provided
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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00057369
Other Study ID Numbers  ICMJE VER001-4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Vicuron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vicuron Pharmaceuticals
Verification Date June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP