Back to resultsTelavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)
Primary Purpose
Gram-Positive Bacterial Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Vancomycin, nafcillin, oxacillin, or cloxacillin
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Positive Bacterial Infections
Eligibility 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
Sites / Locations
- Wellstar Infectious Disease
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telavancin
Vancomycin, nafcillin, oxacillin, or cloxacillin
Arm Description
Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
Outcomes
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00062647
First Posted
June 9, 2003
Last Updated
January 14, 2019
Sponsor
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00062647
Brief Title
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
Acronym
ASSURE
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 Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telavancin
Arm Type
Experimental
Arm Title
Vancomycin, nafcillin, oxacillin, or cloxacillin
Arm Type
Active Comparator
Arm Description
Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
Intervention Type
Drug
Intervention Name(s)
Telavancin
Other Intervention Name(s)
TD-6424, VIBATIV
Intervention Description
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
Intervention Type
Drug
Intervention Name(s)
Vancomycin, nafcillin, oxacillin, or cloxacillin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 weeks after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Ralph Corey, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellstar Infectious Disease
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24884578
Citation
Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miro 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.
Results Reference
derived
Learn more about this trial
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
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