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:
Information provided by:
Theravance BioPharma US, Inc.
ClinicalTrials.gov Identifier:
NCT00107978
First received: April 11, 2005
Last updated: December 10, 2010
Last verified: December 2010
  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
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 US, Inc.:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 7 to 14 days after the last antibiotic dose ] [ Designated as safety issue: No ]
    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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 US, 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: NCT00107978     History of Changes
Other Study ID Numbers: 0018
Study First Received: April 11, 2005
Results First Received: November 3, 2009
Last Updated: December 10, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Pública de Chile
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Department of Health
United Kingdom: Food Standards Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

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

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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014