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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2003 by Vicuron Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vicuron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00057369
First received: March 31, 2003
Last updated: June 23, 2005
Last verified: June 2003
  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 Intervention Phase
Bacteremia
Drug: dalbavancin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vicuron Pharmaceuticals:

Estimated Enrollment: 88
Study Start Date: February 2001
Estimated Study Completion Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057369

Locations
United States, Georgia
Wellstar/Kennestone Hospital
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
Vicuron Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057369     History of Changes
Other Study ID Numbers: VER001-4
Study First Received: March 31, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Dalbavancin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014