1347. A Global Phase 3 Study of Delafloxacin (DLX) Compared to Vancomycin/Aztreonam (VAN/AZ) in Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Session: Poster Abstract Session: Clinical Trials
Friday, October 28, 2016
Room: Poster Hall
Posters
  • IDWeek 2016 efficacy Poster1347.Final Update.10.6.pdf (614.4 kB)
  • Background: Delafloxacin is an IV and oral investigational anionic fluoroquinolone with a full spectrum of activity being developed for the potential of treating a variety of infections including ABSSSI.

    Methods: Multicenter, randomized, double-blind trial of adults with major abscesses, cellulitis, wound or burn infections with ≥ 75 cm2 erythema and ≥ 2 systemic signs. Patients were randomized 1:1 to receive BID DLX 300 mg IV for 3 days with a switch to 450 mg oral, or recommended VAN 15 mg/kg IV with AZ for 5-14 days. The primary endpoint was response at 48-72 hours. A secondary endpoint was investigator‑assessed response based on complete resolution of signs and symptoms (Cure) at Follow up (FU), Day 14 ± 1, and Late Follow up (LFU), Day 21–28. Clinical success was defined as Cure + Improved (no further antibiotics were needed per investigator assessment).

    Results: 850 patients were randomized, of whom 63% were male with mean age 50.7 yrs. Average lesion size was 353 cm2; 48% of patients had cellulitis, 25% abscesses, 26% wound and 1% burn infections. 552 (65%) patients had pathogens identified at baseline. Efficacy data for the intent-to-treat (ITT) population are presented below:

    Key outcomes (ITT)

    DLX

    VAN/AZ

    D-V Delta

    (95% CI)

    n/423 (%)

    n/427 (%)

    Objective Response 48–72 hours

    354 (83.7)

    344 (80.6)

    3.1 (-2.0, 8.3)

    Investigator-Assessed Response

    Cure at FU

    244 (57.7)

    255 (59.7)

    -2.0 (-8.6, 4.6)

    Clinical Success at FU

    369 (87.2)

    362 (84.8)

    2.5 (-2.2, 7.2)

    Cure at LFU

    287 (67.8)

    303 (71.0)

    -3.1 (-9.3, 3.1)

    Clinical Success at LFU

    353 (83.5)

    351 (82.2)

    1.3 (-3.8, 6.3)

    In the micro-evaluable population, DLX was comparable to VAN in eradication of methicillin resistant Staphylococcus aureus (MRSA), 96.0% (48/50) vs 97.0% (32/33) at FU. At least 43.6% DLX and 39.3% VAN patients had at least one treatment-emergent adverse event. The most common DLX events were diarrhea and nausea; which were mild and did not lead to discontinuation. There were similar rates between DLX and VAN of study treatment discontinuations (7.3% vs 8.9%) and serious adverse events (3.8% vs. 4.0%), however the only 2 deaths in the study occurred in VAN/AZ.

    Conclusion: IV/oral DLX was comparable to IV VAN/AZ in treatment of ABSSSI, and DLX was also comparable to VAN in treating patients with MRSA. DLX appears well tolerated with low discontinuation rates.

    W O' Riordan, MD1, Alison Mc Manus, DNP, FNP-BC, CPI1, Juri Teras, MD, FACS2, Ivan Poromanski, MD, PhD3, Maria Cruz Saldariagga, MD4, Megan Quintas, BS5, Laura Lawrence, B.S.5 and Sue K. Cammarata, M.D.5, (1)E Study Site, Chula Vista, CA, (2)Surgery Clinic, North Estonian Medical Centre, Tallinn, Estonia, (3)Purulent-Septic Surgery Clinic, University Multiprofile Hospital Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Bulgaria, (4)Infectious & Tropical Diseases, Hospital Nacional Adolfo Guevara Velasco Essalud, Avenida Anselmo Alvarez S/n, Wanchaq, Cusco, Peru, (5)Melinta Therapeutics, Inc., New Haven, CT

    Disclosures:

    W. O' Riordan, Melinta Therapeutics: Investigator , Research support

    A. Mc Manus, Melinta Therapeutics: Investigator , Research support

    J. Teras, Melinta Therapeutics: Investigator , Research support

    I. Poromanski, Melinta Therapeutics: Investigator , Research support

    M. Cruz Saldariagga, Melinta Therapeutics: Investigator , Research support

    M. Quintas, Melinta Therapeutics, Inc.: Employee , Salary

    L. Lawrence, Melinta Therapeutics, Inc.: Employee , Salary

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

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