1854. Impact of Delafloxacin (DLX) and Vancomycin/Aztreonam (VAN/AZ) on Resolution of Signs and Symptoms of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Session: Poster Abstract Session: Clinical Study with New Antibiotics and Antifungals
Saturday, October 7, 2017
Room: Poster Hall CD
Posters
  • IDWeek 2017 - Poster 1854 - DLX Resolution of S and Sx Final.pdf (188.4 kB)
  • Background:

    Delafloxacin (DLX), an anionic fluoroquinolone antibiotic with Gram-negative and Gram-positive activity including MRSA, is in development for treatment of ABSSSI. In a global phase 3 ABSSSI trial, DLX was non-inferior to VAN/AZ in both objective and clinical response endpoints. Clinical signs and symptoms (S&S) and lesion size measurements also were evaluated in this trial

    Methods:

    A multicenter, double-blind trial of adults with ABSSSI randomized patients 1:1 to receive either DLX monotherapy 300mg q12h IV or VAN 15 mg/kg (actual body weight) with AZ for 5 – 14 days. Aztreonam was discontinued once Gram-negative infection was excluded in the VAN arm. The presence or absence of S&S were collected at each evaluation point. Patients with complete resolution of clinical S&S were classified as complete cures. Lesions were measured by digital planimetry. Patient-reported pain was recorded by numerical rating scale (NRS; 0=no pain, 10=worst pain). Assessments were completed at baseline, during and at end of treatment (EOT), at Follow-up (FU day 14) and Late Follow-up (LFU day 21-28).

    Results:

    660 patients were randomized in US, Europe, and Israel. 63% were male with mean age 46 yrs. 39% had cellulitis, 25% abscesses, 35% wound and 1% burn infections. Baseline erythema and induration were seen in 100% and 98% of patients, respectively. Mean area of erythema and induration at baseline was 307 and 107 cm2 respectively. Most common locations for lesions were lower (40%) and upper extremities (34 %). S. aureus was the most common isolate. Mean days of treatment was 6 days in either group. DLX and VAN/AZ patients had comparable impact on S&S with complete resolution in 27% vs 24 % at EOT, and 52% vs 51% at FU, and 70% vs 67% at LFU for DLX vs VAN/AZ, respectively. DLX was comparable to VAN/AZ in percent reduction in erythema over time (figure). There was a median reduction of 58% vs 59% at 48-72 h, 94% vs 94% at EOT, and 100% vs 100% at LFU for DLX and VAN/AZ respectively. Baseline mean pain scores were 8/10 with scores of ~2.5/10 at EOT and 1/10 at FU for both treatment groups.

    Conclusion:

    Treatment with DLX and VAN/AZ provided rapid improvement in clinical signs and symptoms in ABSSSI with comparable reductions in S&S, lesion size and pain score.

     

    Philip Giordano, MD1, John Pullman, MD2, Laura Lawrence, BS3, Megan Quintas, BS3, Carol Tseng, Ph.D.4 and Sue K. Cammarata, MD5, (1)Orlando Health, Orlando, FL, (2)Mercury Street Medical, Butte, MT, (3)Melinta Therapeutics, Inc., New Haven, CT, (4)H2O Clinical LLC, Hunt Valley, MD, (5)Melinta Therapeutics, Inc., Lincolnshire, IL

    Disclosures:

    P. Giordano, Melinta: Investigator , Research grant

    J. Pullman, Melinta: Investigator , Research grant

    L. Lawrence, Melinta: Employee , Salary

    M. Quintas, Melinta: Employee , Salary

    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.