Overview

This trial is active, not recruiting.

Condition bacteremia
Treatment dalbavancin
Phase phase 2
Sponsor Vicuron Pharmaceuticals
Start date February 2001
End date June 2003
Trial size 88 participants
Trial identifier NCT00057369, VER001-4

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

- 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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Vicuron Pharmaceuticals.