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

Vicuron Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Bacteremia

Treatments

Drug: dalbavancin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00057369

VER001-4

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)