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Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

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.
 
ClinicalTrials.gov Identifier: NCT00062647
Recruitment Status : Completed
First Posted : June 12, 2003
Results First Posted : March 22, 2011
Last Update Posted : January 16, 2019
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : August 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Georgia
Wellstar Infectious Disease
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Principal Investigator: G. Ralph Corey, MD Duke University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00062647    
Other Study ID Numbers: I6424-203a
First Posted: June 12, 2003    Key Record Dates
Results First Posted: March 22, 2011
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Bacterial Infections
Bacteremia
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses
Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Vancomycin
Cloxacillin
Oxacillin
Telavancin
Nafcillin
Anti-Bacterial Agents
Anti-Infective Agents