2377. Outcomes in patients with history of cardiac or vascular disease (CV) during treatment of acute bacterial skin and skin structure infection (ABSSSI) with delafloxacin (DLX) vs vancomycin/aztreonam (VAN/AZ)
Session: Poster Abstract Session: Skin and Skin Structure Infection
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • 2377_IDWPOSTER2018_Cardiac_Oguchi.pdf (130.6 kB)
  • Background: DLX, an anionic fluoroquinolone antibiotic with Gram-positive and Gram-negative activity, was recently approved for treatment of ABSSSI. Two global phase 3 ABSSSI trials (studies 302 and 303) included patients with cardiac or vascular disease.

    Methods: Two multicenter, double-blind, double-dummy trials of adults with ABSSSI patients randomized 1:1 to receive either DLX monotherapy or VAN 15 mg/kg (actual body weight) with AZ for 5 – 14 days. Study 302 used DLX 300mg BID IV only; study 303 used DLX 300mg BID IV for 3 days with a mandatory blinded switch to DLX 450 mg oral BID. Key endpoints were objective response at 48-72 hours with ≥20% reduction in lesion size; and Investigator assessment of outcome based on resolution of signs and symptoms at Follow-up (FU day 14) and Late Follow-up (LFU day 21-28).

    Results: In the two studies, 488 CV patients were randomized in US, Europe, Latin America and Asia. 57% were male with mean age 59 yrs. Average erythema area at baseline was 446 cm2. 58% had cellulitis, 19% abscesses, 22% wound and 1% burns. Key endpoints are below:

    Key Endpoints

    DLX

    VAN/AZ

    n/Total (%)

    n/Total (%)

    Objective response 48-72h (ITT)

    208/260 (80.0%)

    183/228 (80.3%)

    Investigator-Assessed Success (FU CE)

    204/217 (94.0%)

    176/185 (95.1%)

    Investigator-Assessed Success (LFU CE)

    194/207 (93.7%)

    173/182 (95.1%)

    Micro Success (FU ME) for S aureus

    72/74 (97.3%)

    57/61 (93.4%)

    The % of CV patients with at least one treatment-related adverse event (AE) was similar for DLX (22.7%) compared to VAN/AZ (22.4%). There were 2 DLX and 5 VAN/AZ-treated CV patients discontinued due to related AEs. The most frequent treatment-related AEs were gastrointestinal including diarrhea seen in 8.2% and 3.1% of DLX and VAN/AZ patients respectively, generally mild to moderate in nature with no cases of C.difficile diarrhea. There were no cardiac events or deaths attributed to either study drug.

    Conclusion: In CV patients, fixed dose DLX monotherapy was comparable to VAN/AZ in treatment of ABSSSI based on the early objective and investigator assessed responses at FU and LFU. DLX was also comparable to VAN/AZ in treating patients with S. aureus. There were no cardiac events or deaths in either study group. DLX appears effective and well tolerated in CV patients with ABSSSI.

    Godson Oguchi, MD1, Richard Beasley, MD2, Laura Lawrence, BS3, Carol Tseng, PhD4 and Sue K. Cammarata, MD3, (1)Midland Florida Clinical Research Center, LLC, Deland, FL, (2)Health Concepts, Rapid City, SD, (3)Melinta Therapeutics, Inc., New Haven, CT, (4)Firma Clinical, Hunt Valley, MD

    Disclosures:

    G. Oguchi, Melinta Therapeutics, Inc.: Investigator , Research support .

    R. Beasley, Melinta Therapeutics, Inc.: Investigator , Research support .

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

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

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

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.