NCT00057369

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2001

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

March 31, 2003

Last Update Submit

June 23, 2005

Conditions

Bacteremia

Interventions

dalbavancinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wellstar/Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Related Publications (1)

  • 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.

    PMID: 34905144DERIVED

MeSH Terms

Conditions

Bacteremia

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2003

First Posted

April 2, 2003

Study Start

February 1, 2001

Study Completion

June 1, 2003

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

US(1)