1339. An Integrated Analysis of the Efficacy of Dalbavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (abSSSI) from the DISCOVER Program
Session: Poster Abstract Session: Clinical Trials
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • Integrated_Poster_FINAL_IDSA.pdf (89.6 kB)
  • Background:

    Dalbavancin is a lipoglycopeptide antibiotic with activity against Gram-positive pathogens and a long half-life allowing for weekly dosing.  DISCOVER 1 and 2 were identically designed clinical trials of dalbavancin in the treatment of abSSSI.

    Methods:

    Both trials were double-blind, double dummy, pharmacist-unblinded randomized trials in which patients with cellulitis, abscess or wound infection with erythema >75cm2 and either a fever, an elevated white blood cell count >12k cells/mm3 or immature neutrophils >10% were randomized to receive dalbavancin 1 gram IV over 30 minutes on Day 1 and 500 mg IV on Day 8 or Vancomycin 1 gram (or 15mg/kg) IV every 12 hours (q12h) for at least three days with an option to switch to oral linezolid 600 mg  q12h to complete 10-14 days of therapy.  The primary endpoint for FDA was measured at 48-72 hours of therapy with success requiring both cessation of spread of the lesion and complete resolution of fever. Secondary endpoints included clinical status at the end of therapy. Efficacy results from both trials were pooled and the 95%CI adjusted for study.

    Results:

     

    Dalbavancin

    Vancomycin/ linezolid

    Difference 

    (95% Confidence Interval)

    Primary Endpoint  (Early Response, ITT Population)

     

    525/659 (79.7%)

    521/653 (79.8%)

    0.1% (-4.5, 4.2)

    Sensitivity analysis (>20% reduction in lesion area at 48-72 hours, ITT Population)

     

    584/659 (88.6%)

    575/653 ((88.1%)

    0.6% (-2.9, 4.1)

    Clinical Status (End of Treatment, Clinically Evaluable Population)

     

     

    517/570 (90.7%)

    502/545 (92.1%)

    -1.5% (-4.8, 1.9)

    Conclusion:

    Efficacy outcomes for patients with abSSSI given dalbavancin alone are non-inferior to those given vancomycin followed by oral linezolid at both an early timepoint and at the end of therapy.

    Mark Wilcox, MD, Microbiology, Leeds Teaching Hospitals and University of Leeds, Leeds, United Kingdom, Helen Boucher, MD, FIDSA, Tufts New Engl Med Ctr, Boston, MA, George Talbot, MD, Talbot Advisors LLC, Anna Maria, FL, Anita Das, PhD, Inclin, San Francisco, CA, Sailaja Puttagunta, MD, Durata Therapeutics, Branford, CT and Michael Dunne, MD, Durata Therapeutics, Inc., Branford, CT

    Disclosures:

    M. Wilcox, Actelion: Consultant and Research Contractor, Consulting fee and Research support
    Astellas: Consultant and Research Contractor, Consulting fee and Research support
    Biomerieux: Research Contractor, Research support
    Cubist: Consultant and Research Contractor, Consulting fee and Research support
    Pfizer: Consultant, Research Contractor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
    Summit: Research Contractor, Research support
    The Medcine Company: Research Contractor, Research support
    Astra Zeneca: Consultant, Consulting fee
    Bayer: Consultant, Consulting fee
    Durata: Consultant, Consulting fee
    J&J: Consultant, Consulting fee
    Merck: Consultant, Consulting fee
    Nabriva: Consultant, Consulting fee
    Novacta: Consultant, Consulting fee
    Novartis: Consultant, Consulting fee
    Optimer: Consultant, Consulting fee
    Sanofi-Pasteur: Consultant, Consulting fee
    The Medicine Company: Consultant, Consulting fee
    VH Squared: Consultant, Consulting fee
    Viropharma: Consultant, Consulting fee

    H. Boucher, Durata Therapeutics: Consultant, Consulting fee

    G. Talbot, Durata Therapeutics: Scientific Advisor and Shareholder, Consulting fee

    A. Das, Durata Therapeutics: Consultant, Consulting fee

    S. Puttagunta, Durata Therapeutics: Employee, Salary

    M. Dunne, Durata Therapeutics: Employee and Shareholder, Salary

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