Back to resultsSafety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
Primary Purpose
Bacteremia
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dalbavancin
Sponsored by
About this trial
This is an interventional treatment trial for Bacteremia
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)
Sites / Locations
- Wellstar/Kennestone Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00057369
Brief Title
Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2003
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vicuron Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dalbavancin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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)
Facility Information:
Facility Name
Wellstar/Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34905144
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
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