785. Single Dose Treatment with Dalbavancin for Acute Bacterial Skin and Skin Structure Infection
Session: Poster Abstract Session: Antimicrobial Agents: Novel Agents
Friday, October 9, 2015
Room: Poster Hall
Posters
  • Single-dose ABSSSI poster.Final QR.pdf (182.8 kB)
  • Background:

    Dalbavancin is a long acting lipoglycopeptide with activity against gram positive pathogens approved for treatment of acute bacterial skin and skin structure infections (ABSSSI) when 1500 mg is delivered in two doses given one week apart.  Given its pharmacokinetic-pharmacodynamic properties, we undertook a clinical trial of the two-dose regimen compared to the entire dose given as a single intravenous infusion.

    Methods:

    This study was a double-blind, double-dummy trial in patients with ABSSSI who were randomized to receive dalbavancin 1500 mg as a single IV infusion over 30 minutes or 1000 mg IV on Day 1 followed one week later by 500 mg IV.  The primary endpoint was the proportion of patients in each arm with ≥20% reduction in the erythema associated with the infection 48-72 hours after start of treatment.  Non-inferiority was to be declared if the lower limit of the 95% confidence interval (CI) on the difference in the outcomes was >-10% in the intent to treat population (ITT). Clinical outcome based on a composite of clinical measures was assessed on Days 14 and 28 with subset analysis in microbiologically evaluable patients (ME).

    Results:

    698 patients were randomized. Demographic characteristics were equally balanced among both treatment groups. The mean age was 48 years, 89% were white and 45% were enrolled from North America. 48% had cellulitis, 25% had a major abscess and 27% had an infected traumatic wound. 

    Timing

    Outcome measure

    Dalbavancin

     Single Dose

    n/N (%)

    Dalbavancin

    Two-dose

    n/N (%)

    Difference

    (95% CI)

    48-72 hours

    Treatment response (ITT)

    284/349 (81.4)

    294/349 (84.2)

    ‑2.9 (‑8.2 to 2.8)

    Day 14

    Clinical success (ITT)

    293/349 (84.0)

    296/349 (84.8)

    -0.9 (-6.3 to 4.6)

    Day 28

    Clinical success (ITT)

    295/349 (84.5)

    297/349 (85.1)

    -0.6 (-6.0 to 4.8)

    Staphylococcus aureus (ME)

    83/92 (90.2)

    93/97 (95.9)

    MRSA (ME)

    25/27 (92.6)

    37/39 (94.9)

    Treatment emergent adverse event (TEAE)

    70/349 (20.1)

    69/346 (19.9)

    Drug-related TEAE

    25/349 (7.2)

    26/346 (7.5)

    TEAE leading to Discontinuation of Study Drug

    6/349 (1.7)

    5/346 (1.4)

    Conclusion:  

    When delivered as a single 1500 mg infusion for treatment of patients with ABSSSI, dalbavancin is non-inferior to the same total dose delivered as two infusions one week apart and is associated with a similar adverse event profile.

    Michael Dunne, MD, R&D, Actavis, Old Saybrook, CT, Sailaja Puttagunta, MD, Allergan, Plc, Jersey City, NJ, Philip Giordano, MD, Clinical Trials, Orlando Health, Orlando, FL, Dainis Krievins, MD PhD, Surgery, Stradins University Hospital, Riga, Latvia, Michael Zelasky, MS, Biometircs, Actavis, Branford, CT and James Baldasarra, MD, Janssen Cell Therapy, Johnson and Johnson, Spring House, PA

    Disclosures:

    M. Dunne, Actavis: Employee , Salary

    S. Puttagunta, Actavis: Employee , Salary

    P. Giordano, Actavis: Investigator and Speaker's Bureau , Research support and Speaker honorarium

    D. Krievins, Durata Therapeutics: Investigator , Grant recipient

    M. Zelasky, Actavis: Employee , Salary

    J. Baldasarra, Orlando Health: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.