Program Schedule

685
Time to Onset and Duration of Adverse Events in Patients with Acute Bacterial Skin and Skin Structure Infections Treated with Oritavancin The SOLO Studies

Session: Poster Abstract Session: Approach to Clinical Infections
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • IDWEEK_Abstract 685 100614_04 final pdf.pdf (210.4 kB)
  • Background: Oritavancin (ORI) is a lipoglycopeptide antibiotic characterized by rapid, concentration dependent bactericidal activity against Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA), and by a long terminal half-life (245 hours) which allows for single dose treatment.  The objective of this analysis is to evaluate the time to onset and duration of adverse events (AEs) in two phase 3 studies (SOLO I and II) in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

    Methods: The SOLO studies were global, multi-center, randomized, double-blind studies with identical design evaluating single dose IV ORI (1200 mg) vs IV vancomycin(VAN, 1 g or 15 mg/kg, every 12 hours for 7 to 10 days) in adults with ABSSSI.    Safety assessments included vital signs, ECG, safety laboratory analysis and occurrence of AEs and serious AEs (SAEs).  An extended safety follow up assessment was conducted at Day 60 (+ 7days). 

    Results:   A total of 976 and 983 patients received ORI and VAN, respectively.  The overall incidences of AE, SAE and AE leading to study drug discontinuation were similar between ORI (55.3%, 5.8% and 3.7%) and VAN (56.9%, 5.9% and 4.2%) treatments.  Median time to onset and durations of AEs in both groups were the same (2 days and 3 days, respectively).  The majority of AEs occurred within the first three days of the study (64.8% in ORI, 66.2% in VAN).  The incidences of AE onset and AE duration by time intervals as outlined in Figures 1 and 2 were similar between treatment groups.

    Conclusion: The long terminal half-life of ORI does not prolong time to onset or duration of AEs.  Single IV dose of 1200 mg ORI was well tolerated in ABSSSI patients. 

    Figure 1:  Time to Onset of Adverse Events by Time Interval

    Figure 2:  Duration of Adverse Events by Time Interval

    Ralph Corey, MD1, W O'riordan, MD2, Norman Huang, MD3, Hai Jiang3, Samantha Good3, Philip Giordano, MD4 and Matthew Wikler, MD3, (1)Medicine - Infectious Diseases, Duke University Medical Center, Durham, NC, (2)Paradise Valley Hospital and e-StudySite, San Diego, CA, (3)The Medicines Company, Parsippany, NJ, (4)Clinical Trials, Orlando Health, Orlando, FL

    Disclosures:

    R. Corey, The Medicines Company: Investigator, Grant recipient

    W. O'riordan, The Medicines Company: Investigator, Grant recipient

    N. Huang, The Medicines Company: Consultant, Salary

    H. Jiang, The Medicines Company: Employee, Salary

    S. Good, The Medicines Company: Employee, Salary

    P. Giordano, The Medicines Company: Investigator, Grant recipient

    M. Wikler, The Medicines Company: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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