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 : January 16, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Staphylococcal Skin Infection | Drug: Telavancin Drug: Vancomycin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 862 participants |
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 |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Telavancin |
Drug: Telavancin
Telavancin 10 mg/kg/day, IV for up to 14 days.
Other Names:
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Active Comparator: Vancomycin |
Drug: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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 (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.

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 |
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 |
Other Study ID Numbers: |
0017 |
First Posted: | September 21, 2004 Key Record Dates |
Results First Posted: | December 8, 2009 |
Last Update Posted: | January 16, 2019 |
Last Verified: | January 2019 |
staph MRSA cSSSI |
Infection Communicable Diseases Cellulitis Skin Diseases, Infectious Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Suppuration |
Connective Tissue Diseases Inflammation Pathologic Processes Skin Diseases Skin Diseases, Bacterial Vancomycin Telavancin Anti-Bacterial Agents Anti-Infective Agents |