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Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00062647
First Posted: June 12, 2003
Last Update Posted: April 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
  Purpose
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: Quadruple (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
  • VIBATIV
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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062647


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00062647     History of Changes
Other Study ID Numbers: I6424-203a
First Submitted: June 9, 2003
First Posted: June 12, 2003
Results First Submitted: December 2, 2009
Results First Posted: March 22, 2011
Last Update Posted: April 4, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Bacterial Infections
Bacteremia
Gram-Positive Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vancomycin
Telavancin
Cloxacillin
Oxacillin
Nafcillin
Anti-Bacterial Agents
Anti-Infective Agents