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

This study is no longer recruiting patients.

Sponsored by: Vicuron Pharmaceuticals
Information provided by: Vicuron Pharmaceuticals

Purpose

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 Treatment or Intervention Phase
Bacteremia
 Drug: dalbavancin
Phase II

MedlinePlus related topics:  Bacterial Infections;   Sepsis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  88

Study start: February 2001;  Study completion: June 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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)

Location Information


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

More Information

Study ID Numbers:  VER001-4
Record last reviewed:  June 2003
Last Updated:  November 5, 2004
Record first received:  March 31, 2003
ClinicalTrials.gov Identifier:  NCT00057369
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources