Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS1)
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|ClinicalTrials.gov Identifier: NCT00091819|
Recruitment Status : Completed
First Posted : September 21, 2004
Results First Posted : December 8, 2009
Last Update Posted : December 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcal Skin Infection||Drug: Telavancin Drug: Vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||862 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
Telavancin 10 mg/kg/day, IV for up to 14 days.
|Active Comparator: Vancomycin||
Vancomycin 1 Gm IV q 12 hrs for up to 14 days.
- Clinical Response [ Time Frame: 7-14 days following end of antibiotic treatment ]The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation 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.
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): NCT00091819
|United States, California|
|Paradise Valley Hospital, 2400 E. 4th Street|
|National City, California, United States, 91950|
|Principal Investigator:||G. Ralph Corey, MD||Duke University|