1338. Microbiologic Analyses of Target Pathogens Identified in the Dalbavancin DISCOVER Program
Session: Poster Abstract Session: Clinical Trials
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • 9-25_Micro_Poster_IDSA.pdf (87.7 kB)
  • Background:

    Dalbavancin a lipoglycopeptide antibiotic with potent in vitro activity against Gram-positive pathogens is in development for the treatment of acute bacterial skin and skin structure infections.  The DISCOVER program comprised two global phase 3 trials comparing dalbavancin alone to vancomycin with an option to switch to oral linezolid.

    Methods:

    Gram-positive pathogens including Staphylococcus aureus and streptococcal spp. isolated at baseline in the two DISCOVER studies were tested in a central laboratory in vitro for susceptibility to a panel of antibiotics and underwent polymerase chain reaction (PCR) testing for mecA and the Panton-Valentine Leukocidin (PVL) toxin.

    Results:

     

                             S. aureus

    S. pyogenes

    S. agalactiae

    S. constellatus

     

    All

    MRSA

    MSSA

     

     

     

    Number of Pathogens

    511

    135

    361

    77

    20

    25

    MIC Range

    0.008-0.25

    0.015-0.25

    0.015-0.25

    0.002-0.25

    <0.001-0.06

    <0.001-0.06

    MIC 50

    0.06

    0.06

    0.06

    0.015

    0.015

    0.008

    MIC 90

    0.06

    0.06

    0.06

    0.06

    0.03

    0.015

    No Gram-positive organism identified after treatment with either dalbavancin or vancomycin/linezolid was found to have a >2x increase in in vitro susceptibility relative to baseline. 357 of the 639 (56%) Staphylococcus aureus isolates recovered at baseline from 572 patients were positive for the PVL toxin.

    Conclusion:

    Consistent with ongoing surveillance studies, in the DISCOVER registration studies the MIC90 of dalbavancin for S. aureus (whether MRSA or MSSA) was < 0.06 mg/ml; the MIC90 for target streptococci was < 0.06 mg/ml.  These data confirm the potent activity of dalbavancin against key Gram-positive pathogens in abSSSIs.

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

    Disclosures:

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

    H. Boucher, Durata Therapeutics: Consultant, Consulting fee

    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

    S. Puttagunta, Durata Therapeutics: Employee, Salary

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

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