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

Sponsor
Vicuron Pharmaceuticals (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00057369
Collaborator
(none)
88
Enrollment
1
Location
27.9
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2001
Study Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • 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

    Locations

    Site City State Country Postal Code
    1 Wellstar/Kennestone Hospital Marietta Georgia United States 30060

    Sponsors and Collaborators

    • Vicuron Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00057369
    Other Study ID Numbers:
    • VER001-4
    First Posted:
    Apr 2, 2003
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jun 1, 2003
    Additional relevant MeSH terms:
    Bacteremia
    Sepsis
    Dalbavancin

    Study Results

    No Results Posted as of Jun 24, 2005