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Sponsored by: |
Theravance |
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Information provided by: | Theravance |
ClinicalTrials.gov Identifier: | NCT00091819 |
Study 0017 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.
Condition | Intervention | Phase |
---|---|---|
Staphylococcal Skin Infection |
Drug: Telavancin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) either suspected or confirmed as the major cause of the infection:
* major abscess requiring surgical incision and drainage * infected burn * deep/extensive cellulitis * infected ulcer * wound infections
Exclusion Criteria:
United States, California | |
Paradise Valley Hospital | |
National City, California, United States, 91950 |
Principal Investigator: | G. Ralph Corey, MD | Duke Clinical Research Center |
Study ID Numbers: | 0017 |
Study First Received: | September 17, 2004 |
Last Updated: | August 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00091819 |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Skin Diseases, Infectious Methicillin |
Skin Diseases Skin Diseases, Bacterial Vancomycin Staphylococcal Skin Infections |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |