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Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gram-Positive Bacterial Infections

Intervention: Telavancin (Drug); Vancomycin, nafcillin, oxacillin, or cloxacillin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
G. Ralph Corey, MD, Principal Investigator, Affiliation: Duke University


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.

Clinical Details

Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- Documented S. aureus bacteremia

Exclusion Criteria

- Patients who had received or would have received more than 72 hours of potentially

effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid

Locations and Contacts

Wellstar Infectious Disease, Marietta, Georgia 30060, United States
Additional Information

Starting date: August 2003
Last updated: March 30, 2011

Page last updated: August 23, 2015

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