Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Phase 2

Completed

• Conditions: Gram-Positive Bacterial Infections
• Interventions: Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin; Drug: Telavancin

• Registration Number: NCT00062647
• Lead Sponsor: Cumberland Pharmaceuticals

Brief Summary

The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-06-09
• Study First Submitted QC: 2003-06-11
• Study First Posted: 2003-06-12
• Study Start: 2003-08
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Results First Submitted: 2009-12-02
• Results First Submitted QC: 2011-02-22
• Results First Posted: 2011-03-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin, nafcillin, oxacillin, or cloxacillin	Vancomycin, nafcillin, oxacillin, or cloxacillin	Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
Telavancin	Telavancin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation	12 weeks after start of treatment	Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.

Trial Locations

Locations (1)

Wellstar Infectious Disease; 🇺🇸 Marietta, Georgia, United States