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Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

This study has been completed.
Information provided by:
Theravance Biopharma Antibiotics, Inc. Identifier:
First received: June 9, 2003
Last updated: March 30, 2011
Last verified: March 2011
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.

Condition Intervention Phase
Gram-Positive Bacterial Infections Drug: Telavancin Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Resource links provided by NLM:

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 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.

Enrollment: 60
Study Start Date: August 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telavancin Drug: Telavancin
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
Other Names:
  • TD-6424
Active Comparator: Vancomycin, nafcillin, oxacillin, or cloxacillin
Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin
Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00062647

United States, Georgia
Wellstar Infectious Disease
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Principal Investigator: G. Ralph Corey, MD Duke University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc. Identifier: NCT00062647     History of Changes
Other Study ID Numbers: I6424-203a
Study First Received: June 9, 2003
Results First Received: December 2, 2009
Last Updated: March 30, 2011

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 16, 2017