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

April 11, 2005
December 10, 2010
February 2005
May 2006   (final data collection date for primary outcome measure)
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.
Clinical response
Complete list of historical versions of study NCT00107978 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
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 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Staphylococcal Skin Infection
  • Drug: Telavancin
    Telavancin 10 mg/kg/day, IV for up to 14 days.
    Other Names:
    • VIBATIV
    • TD-6424
  • Drug: Vancomycin
    Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
  • Experimental: Telavancin
    Intervention: Drug: Telavancin
  • Active Comparator: Vancomycin
    Intervention: Drug: Vancomycin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1035
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107978
0018
Yes
Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
Theravance Biopharma Antibiotics, Inc.
Not Provided
Principal Investigator: G. Ralph Corey, MD Duke University
Theravance Biopharma Antibiotics, Inc.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP