Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)
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|ClinicalTrials.gov Identifier: NCT00107978|
Recruitment Status : Completed
First Posted : April 12, 2005
Results First Posted : February 1, 2010
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 :||1035 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 :||February 2005|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
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.
- Clinical Response [ Time Frame: 7 to 14 days after the last antibiotic dose ]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.
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): NCT00107978
|United States, Louisiana|
|Louisiana State University Health Sciences Center, Dept of Med/ER Med|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||G. Ralph Corey, MD||Duke University|