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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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dalbavancin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Wellstar/Kennestone Hospital

Marietta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 34905144 (View on PubMed)

Other Identifiers

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VER001-4

Identifier Type: -

Identifier Source: org_study_id