1858. Comparison of Safety Profile of Delafloxacin (DLX) versus Vancomycin/Aztreonam (VAN/AZ) in theTreatment of Patients (Pts) with Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Integrated Safety Findings from Two Phase III Studies
Session: Poster Abstract Session: Clinical Study with New Antibiotics and Antifungals
Saturday, October 7, 2017
Room: Poster Hall CD
Posters
  • IDWeek 2017 - Poster 1858 - DLX Safety.pdf (397.9 kB)
  • Background: DLX is an investigational novel fluoroquinolone in development for the treatment of adult pts with ABSSSI. The objective of this analysis was to compare the incidence of adverse events between DLX and VAN/AZ across two phase III registrational ABSSSI studies.

    Methods:

    Study design and population: two global multi-center, double-blind randomized Phase 3 trials of adults with ABSSSI who receive either DLX IV/oral monotherapy q12h or VAN 15mg/kg with AZ q12H for 5 – 14 days. Collected safety data included all reported AEs (baseline to 30 days after the final dose of study drug). Adverse events were reported by the blinded investigator who also assessed whether the reported events were potentially related to the treatment. Pre-specified laboratory tests were also collected from baseline through day 21-28.

    Results:

    Across the 2 studies, 1492 ABSSSI pts received at least one dose of treatment. Mean age was 49 years; 13% >age 65. Among the 1492 pts, 42% were obese, 11% were diabetic, and 16% had renal impairment. Overall, rates of any AE were comparable between treatment groups (table). The most common AEs were gastrointestinal, seen in 17% and 13% of DLX and VAN/AZ pts, respectively. Less than <1% of DLX pts discontinued treatment due to related AEs. For DLX and VAN/AZ, there were 1.1% and 1.7% pts with ALT>5X ULN at any time in the study. There was one case of C. difficile infection on DLX in a patient with prior Bactrim/clindamycin therapy. There was no increase in events previously associated with FQs compared to VAN/AZ. There were no cases of tendon rupture or reports of pts with symptoms consistent with FQAD.

    % patients with at least one:

    DLX

    N=741

    VAN/AZ

    N=751

    Any Adverse event report (AE)

    45.1

    47.7

    Diarrhea#

    7.8

    3.2

    Nausea

    7.6

    6.3

    Vomiting

    2.3

    2.4

    Headache

    3.2

    6.7

    Abnormal Liver function tests*

    3.1

    4.0

    Treatment Related AE

    22.1

    26.1

    Moderate to severe AE

    18.3

    20.2

    AE leading to drug discontinuation

    1.8

    3.5

    Related AE leading to drug discontinuation

    0.8

    2.4

    Serious AE (SAE)

    3.6

    3.5

    Related SAE

    0.3

    0.5

    Deaths (none considered treatment related)

    0.1

    0.4

    # selected events reported ≥2% DLX pts regardless of causality *pooled reports

    Conclusion:

    Overall, the safety profile of DLX was comparable to VAN/AZ among patients with ABSSSI.

    G. Ralph Corey, MD, Duke University Medical Center, Durham, NC, David Hooper, MD, FIDSA, Infection Control Unit, Massachusetts General Hospital, Boston, MA, Thomas P. Lodise Jr., PharmD, PhD, Albany College of Pharmacy and Health Sciences, Albany, NY, Carol Tseng, Ph.D., H2O Clinical LLC, Hunt Valley, MD and Sue K. Cammarata, MD, Melinta Therapeutics, Inc., Lincolnshire, IL

    Disclosures:

    G. R. Corey, Melinta: Consultant , Consulting fee

    D. Hooper, Melinta: Consultant , Consulting fee

    T. P. Lodise Jr., Melinta: Consultant , Consulting fee

    C. Tseng, Melinta: Consultant and Research Contractor , Consulting fee

    S. K. Cammarata, Melinta Therapeutics: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.