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

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00057369
• Other study ID #: VER001-4
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 31, 2003
• Last updated: June 23, 2005
• Start date: February 2001
• Est. completion date: June 2003

Study information

• Verified date: June 2003
• Source: Vicuron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• dalbavancin

Locations

Country	Name	City	State
United States	Wellstar/Kennestone Hospital	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States,