1329. Comparison of Early Achievement of >20% Reduction in Lesion Size of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) between Patients who Received Oritavancin or Vancomycin in SOLO 1
Session: Poster Abstract Session: Clinical Trials
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • IDSA 2013 poster v01c.pdf (392.5 kB)
  • Background: The Biomarkers Consortium of the Foundation for the National Institutes of Health recommended that success in ABSSSI registrational trials be defined as achieving >20% reduction in lesion size at 48 to 72 hours after randomization.  In light of this recommendation, this analysis sought to compare the incidences in achieving this endpoint between patients who received oritavancin or vancomycin in SOLO 1 at hours 48 and 72 post the initiation of study medication. 

    Methods: SOLO 1 is the first of two multicenter, double blind, randomized studies to evaluate the efficacy and safety of single-dose (1200 mg) IV oritavancin versus 7-10 days of IV vancomycin (1g or 15mg/kg bid)  for the treatment of patients with ABSSSI infection. The SOLO study protocols were amended to allow patients to complete antimicrobial therapy in the ambulatory setting at the discretion of the investigator. Ambulatory patients received antibiotic infusions either at their homes or at outpatient parenteral antibiotic therapy (OPAT) centers. Clinical response was monitored and assessed at regular intervals following initial treatment.  For this analysis, achievement of >20% reduction of lesion spread was determined at hours 48 and 72. 

    Results: Overall, 83.5% and 92.4% of patients achieved >20% reduction in lesion size within 48 and 72 hours, respectively (See table).   At hour 48, response rate was 85.0% in the oritavancin group vs. 82.1% in the vancomycin group (difference: 2.9%; 95% confidence interval (CI):  -1.9- 7.7).  At hour 72, response rate was 93.6% in the oritavancin group vs. 91.2% in the vancomycin group (difference: 2.4%; 95% CI:  -1.0- 5.8).

    Conclusion: Similar achievement of >20% reduction of lesion spread was noted between oritavancin and vancomycin at hours 48 and 72. 

    Table:  Summary of Lesion Size Percent Change from Baseline over Time (mITT population)

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                                                  Oritavancin                   Vancomycin

    >20% Reduction                       (N=475)                       (N=479)                 Diff and 95% CI

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     At 48 Hours                            396/466 (85.0%)         380/463 (82.1%)      2.9 [-1.9,   7.7]

     At 72 Hours                            440/470 (93.6%)          427/468 (91.2%)      2.4 [-1.0,   5.8]

    Kenneth T. Lapensee, Ph.D., M.P.H.1, Thomas Lodise, PharmD2, Norman Huang, MD1, Hai Jiang, PhD1, Weihong Fan, MS1 and Mike Mcguire1, (1)The Medicines Company, Parsippany, NJ, (2)Albany College of Pharmacy and Health Sciences, Albany, NY

    Disclosures:

    K. T. Lapensee, The Medicines Company: Employee, Salary

    T. Lodise, Albany College of Pharmacy and Health Sciences: Employee, Salary
    The Medicines Company: Consultant, Consulting fee

    N. Huang, The Medicines Company: Consultant, Consulting fee

    H. Jiang, The Medicines Company: Employee, Salary

    W. Fan, The Medicines Company: Employee, Salary

    M. Mcguire, The Medicines Company: Employee, Salary

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