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:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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: 7-14 days following end of antibiotic treatment ] [ Designated as safety issue: No ]
    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:
  • VIBATIV
  • TD-6424
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
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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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:
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
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Croatia: Ministry of Science, Education and Sports
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Malaysia: Ministry of Health
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
staph
MRSA
cSSSI

Additional relevant MeSH terms:
Skin Diseases, Infectious
Staphylococcal Skin Infections
Staphylococcal Infections
Infection
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Methicillin
Vancomycin
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014