Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

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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

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

Drug Information available for: Oxacillin Nafcillin Cloxacillin sodium Nafcillin sodium Oxacillin sodium Vancomycin Vancomycin hydrochloride Telavancin Telavancin hydrochloride

U.S. FDA Resources

Arms and Interventions

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

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.

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

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

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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miró JM, Fowler VG Jr, Barriere SL, Kitt MM, Corey GR. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.

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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 Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes	Vancomycin Cloxacillin Telavancin Oxacillin Nafcillin Anti-Bacterial Agents Anti-Infective Agents

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