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Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107978
First Posted: April 12, 2005
Last Update Posted: December 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
  Purpose
Study 0018 (NCT00107978) 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:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 1035
Study Start Date: February 2005
Study Completion Date: May 2006
Primary Completion Date: May 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:
  • VIBATIV
  • TD-6424
Active Comparator: Vancomycin Drug: Vancomycin
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

  Eligibility

Information from the National Library of Medicine

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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 MRSA (Methicillin-resistant Staphylococcus Aureus) 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
  • Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Louisiana
Louisiana State University Health Sciences Center, Dept of Med/ER Med
New Orleans, Louisiana, United States, 70112
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: NCT00107978     History of Changes
Other Study ID Numbers: 0018
First Submitted: April 11, 2005
First Posted: April 12, 2005
Results First Submitted: November 3, 2009
Results First Posted: February 1, 2010
Last Update Posted: December 28, 2010
Last Verified: December 2010

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
cSSSI (complicated Skin and Skin Structure Infections)
Staph (Staphylococcus)
MRSA (Methicillin-resistant Staphylococcus Aureus)

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