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Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS1)
This study has been completed.
Sponsor:
Theravance Biopharma Antibiotics, Inc.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT00091819
First received: September 17, 2004
Last updated: December 10, 2010
Last verified: December 2010
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Purpose
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 Drug: Vancomycin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
MedlinePlus related topics:
MRSA
Drug Information available for:
Vancomycin
Vancomycin hydrochloride
Telavancin
Telavancin hydrochloride
U.S. FDA Resources
Further study details as provided by Theravance Biopharma Antibiotics, Inc.:
Primary Outcome Measures:
- 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.
| Enrollment: | 862 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Telavancin |
Drug: Telavancin
Telavancin 10 mg/kg/day, IV for up to 14 days.
Other Names:
|
| Active Comparator: Vancomycin |
Drug: Vancomycin
Vancomycin 1 Gm IV q 12 hrs for up to 14 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 (see exclusion criteria for important qualifications)
- deep/extensive cellulitis
- infected ulcer (see exclusion criteria for important qualifications)
- wound infections
- Patients must be expected to require at least 7 days of intravenous antibiotic treatment
Exclusion Criteria:
- Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy prior to randomization
- Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00091819
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091819
Locations
| United States, California | |
| Paradise Valley Hospital, 2400 E. 4th Street | |
| National City, California, United States, 91950 | |
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Investigators
| Principal Investigator: | G. Ralph Corey, MD | Duke University |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc. |
| ClinicalTrials.gov Identifier: | NCT00091819 History of Changes |
| Other Study ID Numbers: |
0017 |
| Study First Received: | September 17, 2004 |
| Results First Received: | November 3, 2009 |
| Last Updated: | December 10, 2010 |
Keywords provided by Theravance Biopharma Antibiotics, Inc.:
|
staph MRSA cSSSI |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Staphylococcal Infections Skin Diseases, Infectious Staphylococcal Skin Infections Gram-Positive Bacterial Infections Bacterial Infections |
Skin Diseases Skin Diseases, Bacterial Vancomycin Methicillin Telavancin Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on August 23, 2017