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

This study is ongoing, but not recruiting participants.

First Received: March 31, 2003 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Vicuron Pharmaceuticals
Information provided by:	Vicuron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00057369

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 II

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

Resource links provided by NLM:

Drug Information available for: Dalbavancin Vancomycin

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Bacterial Agents
Sepsis

Dalbavancin
Vancomycin
Bacteremia
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Sepsis
Dalbavancin

Pathologic Processes
Therapeutic Uses
Bacteremia
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on July 02, 2009