Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)
This study has been completed.
Information provided by:
First received: April 11, 2005
Last updated: December 10, 2010
Last verified: December 2010
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
Staphylococcal Skin Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus|
Resource links provided by NLM:
Drug Information available for: Vancomycin Vancomycin hydrochloride Staphylococcus aureus TelavancinU.S. FDA Resources
Further study details as provided by Theravance, Inc.:
Primary Outcome Measures:
- Clinical Response [ Time Frame: 7 to 14 days after the last antibiotic dose ] [ Designated as safety issue: No ]The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
|Study Start Date:||February 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Telavancin 10 mg/kg/day, IV for up to 14 days.
|Active Comparator: Vancomycin||
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107978
|United States, Louisiana|
|Louisiana State University Health Sciences Center, Dept of Med/ER Med|
|New Orleans, Louisiana, United States, 70112|
Sponsors and Collaborators
|Principal Investigator:||G. Ralph Corey, MD||Duke University|