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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:

Study Description
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.

Condition or disease Intervention/treatment Phase
Bacteremia Drug: dalbavancin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2001
Estimated Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057369


Locations
United States, Georgia
Wellstar/Kennestone Hospital
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
Vicuron Pharmaceuticals
More Information

ClinicalTrials.gov Identifier: NCT00057369     History of Changes
Other Study ID Numbers: VER001-4
First Posted: April 2, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vancomycin
Dalbavancin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents