CClinicalTrials.gg
Status unknownNCT00057369Updated Jun 24, 2005

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

A Phase 2 interventional study of dalbavancin in Bacteremia, sponsored by Vicuron Pharmaceuticals. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Vicuron Pharmaceuticals · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2003), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bacteremia
03

In context

Bacteremia

322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.

This study's enrollment of 88 is below the median of 149 across 171 interventional studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

This is the only study on the registry with Vicuron Pharmaceuticals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
88 participants

Interventions

  • Drugdalbavancin
06

Study locations

1 site
  • Wellstar/Kennestone Hospital
    Marietta, Georgia 30060, United States
07

References and documents

Publications

  • Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14. PubMed 34905144 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00057369
Lead sponsor
Vicuron Pharmaceuticals
First posted
Apr 2, 2003
Start date
Feb 2001
Completion
Jun 2003
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.

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