2378. Resolution of Signs and Symptoms (S&S) of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) with Delafloxacin (DLX) IV/Oral Therapy
Session: Poster Abstract Session: Skin and Skin Structure Infection
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • 2378_IDWPOSTER_Signs and Symptoms_Pullman.pdf (278.3 kB)
  • Background:   Delafloxacin, a fluoroquinolone antibiotic with Gram-negative and Gram-positive activity including MRSA, was approved for treatment of ABSSSI. In a 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 patients randomized 1:1 to receive either DLX monotherapy 300mg q12h IV with switch to oral 450 mg q12h or vancomycin (VAN) 15 mg/kg (actual body weight) with aztreonam (AZ) for 5 – 14 days. AZ was discontinued once Gram-negative infection was excluded in the VAN arm. The presence or absence of clinical S&S were collected at each evaluation timepoint. Patients with complete resolution of 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:   850 patients were randomized in US, Europe, Asia and Latin America. 63% were male with mean age 51 yrs. 48% had cellulitis, 25% abscesses, 26% wound and 1% burn infections. Baseline erythema and induration were reported in 100% and 93% of patients, respectively. Mean area of erythema and induration at baseline was 353 and 138 cm2 respectively. Most common locations for lesions were lower extremities (56%) and upper extremities (24 %). S. aureus was the most common isolate. Mean days of treatment was 7 days in either group. DLX and VAN/AZ patients had comparable impact on S&S with complete resolution in 42% vs 45 % at EOT, and 58% vs 60% at FU, and 68% vs 71% at LFU respectively. DLX was comparable to VAN/AZ in percent reduction in erythema over time (figure). There was a mean reduction of 58% vs 53% at 48-72 h, 90% vs 87% at EOT, and 98% vs 97% at LFU for DLX and VAN/AZ respectively (figure). Baseline mean pain scores were 7/10 with scores of ~1/10 at EOT and ~0.5/10 at FU for both treatment groups.

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

     

     

    John Pullman, MD1, William O' Riordan, MD2, Laura Lawrence, BS3, Megan Quintas, BS3, Carol Tseng, PhD4 and Sue K. Cammarata, MD3, (1)Mercury Street Medical, Butte, MT, (2)eStudySite, San Diego, CA, (3)Melinta Therapeutics, Inc., New Haven, CT, (4)Firma Clinical, Hunt Valley, MD

    Disclosures:

    J. Pullman, Melinta Therapeutics, Inc.: Investigator , Research support .

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

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

    M. Quintas, 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 and Shareholder , Salary .

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