Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gram-Positive Bacterial Infections
Intervention: Telavancin (Drug); Vancomycin, nafcillin, oxacillin, or cloxacillin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Theravance Biopharma Antibiotics, Inc. Official(s) and/or principal investigator(s):
G. Ralph Corey, MD, Principal Investigator, Affiliation: Duke University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Wellstar Infectious Disease, Marietta, Georgia 30060, United States
Additional Information
Starting date: August 2003
Last updated: March 30, 2011
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