783. Outcomes in Obese Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in a Trial Comparing Delafloxacin (DLX)  to Vancomycin/Aztreonam (VAN)
Session: Poster Abstract Session: Antimicrobial Agents: Novel Agents
Friday, October 9, 2015
Room: Poster Hall
Posters
  • 2015 302 Obese_data final.pdf (203.7 kB)
  • Background: Delafloxacin (DLX) is an investigational, broad-spectrum fluoroquinolone antibiotic. Obese patients in the clinic are generally therapeutically more challenging than non-obese.  In a phase 2 trial (RX-3341-202), DLX exhibited statistically better outcomes compared to vancomycin (VAN) in obese patients, body mass index (BMI) ≥30 kg/m2, with ABSSSI.

    Methods: Phase 3 trial of adults with ABSSSI (lesion size ≥75 cm2; ≥2 signs of systemic infection). Patients received DLX IV BID 300 mg or VAN 15 mg/kg with aztreonam for 5–14 days. Primary endpoint was ≥20% reduction in lesion size at 48 to 72 hours. Secondary endpoint was investigator‑assessed response based on resolution of signs and symptoms (Cure) at the Follow up (FU) and Late Follow Up (LFU) visits.

    Results: Of 660 patients randomized, 214 patients had BMI ≥30 kg/m2. 54% male; mean age 48.3 yrs; 17% were diabetic. Average erythema area at baseline was 417 cm2.  Obese subjects were older, more likely to be diabetic, have larger lesions, cellulitis, and lower extremity lesions vs. non-obese patients.  Efficacy data for the intent-to-treat (ITT) and microbiologically evaluable (ME) populations are presented below:

    Outcomes in Obese Patients

    DLX

    VAN

    Delta

    (95% CI)

    n/Total (%)

    n/Total (%)

    Objective Response 48–72 hours (ITT)

    90/120 (75.0)

    70/94 (74.5)

    –0.532 (–12.51, 11.05)

    Investigator-Assessed Cure at FU (ITT)

    68/120 (56.7)

    42/94 (44.7)

             –11.986 (–25.08, 1.54)

    Investigator-Assessed Cure at LFU (ITT)

    86/120 (71.7)

    54/94 (57.4)

    –14.220 (–26.90, –1.34)

    Microbiological Response at LFU (ME) with MRSA at Baseline

    22/22 (100.0)

    14/15 (93.3)

    –6.667 (–30.23, 9.18)

    The overall % of obese patients with at least one treatment-emergent adverse event (AE) was higher for VAN (63.4) vs. DLX (54.2). The most common treatment-related AEs in obese patients (in both treatment groups) were nausea and diarrhea.

    Conclusion: In obese patients, at the early endpoint at 48-72 hrs, outcome with DLX was similar to VAN. For the investigator-assessed outcomes, DLX had a numerically higher outcome at FU and a statistically better outcome at the LFU compared to VAN. DLX was well tolerated in these patients. DLX may offer an alternative therapy that does not require dose adjustment and monitoring in obese patients.

    Lajos Kemény, MD1, Christopher Lucasti, MD2, Eugene Sun, MD3, Megan Quintas, BA3, Laura Lawrence, BS3 and Sue Cammarata, MD3, (1)Deprtment of Dermatology and Allergology, University of Szeged, Szeged, Hungary, (2)South Jersey Infectious Diseases, Somers Point, NJ, (3)Melinta Therapeutics, New Haven, CT

    Disclosures:

    L. Kemény, Melinta Therapeutics: Investigator , Research support

    C. Lucasti, Melinta Therapeutics: Investigator , Research support

    E. Sun, Melinta Therapeutics: Employee , Salary

    M. Quintas, Melinta Therapeutics: Employee , Salary

    L. Lawrence, Melinta Therapeutics: Employee , Salary

    S. Cammarata, Melinta Therapeutics: 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.