Rapid Decrease in Lesion Size and Pain With Delafloxacin in ABSSSI

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Delafloxacin, an anionic fluoroquinolone antibiotic, was recently approved in the US as both an IV and oral tablet formulation for the treatment of ABSSSI.
Delafloxacin, an anionic fluoroquinolone antibiotic, was recently approved in the US as both an IV and oral tablet formulation for the treatment of ABSSSI.

This article is part of Infectious Disease Advisor's in-depth coverage of IDWeek 2017™, which took place in San Diego, CA. Our staff will be reporting on the latest treatment advancements and research initiatives for skin infections. Check back regularly for highlights from IDWeek 2017.

In patients with acute bacterial skin and skin structure infection (ABSSSI), comparable reductions in clinical signs and symptoms, lesion size, and pain score were observed after treatment with either delafloxacin (Baxdela™, Melinta Therapeutics, Inc.) or a combination of vancomycin/aztreonam, according to research presented at IDWeek 2017, held from October 4-8 in San Diego, California.

In a global, multicenter, double-blind, phase 3 trial, adults with ABSSSI were randomly assigned 1:1 to receive either delafloxacin monotherapy 300 mg intravenously (IV) every 12 hours or vancomycin 15 mg/kg IV (actual body weight) and aztreonam for between 5 and 14 days. Once gram-negative infection was excluded, aztreonam was discontinued. Complete resolution of clinical signs and symptoms were classified as complete cures, with digital planimetry used to measure lesions. A numeric rating scale (0 = no pain, 10 = worst pain) was used to record pain. Assessment was completed at baseline and during treatment. Follow-up for evaluation of outcomes was at 14 days and 21 to 28 days (late follow-up).

Of the 660 patients, 63% were men (mean age, 46 years). Patients had cellulitis (39%), abscesses (35%), wound infections (35%), and burn infections (1%). Baseline patient characteristics included erythema (100%; mean area 307 cm2) and induration (98%; mean area 107 cm2). Staphylococcus aureus was the most common isolate, and the lower (40%) and upper (35%) extremities were the most common locations for lesions. Treatment duration was an average of 6 days.

Complete resolution of clinical signs and symptoms were comparable in the delafloxacin and vancomycin/ aztreonam groups at end of treatment (22% vs 19%, respectively), at follow-up (52% vs 51%, respectively), and at late follow-up (70% vs 67%, respectively). Erythema decreased similarly between the delafloxacin and vancomycin/ aztreonam groups. Median reduction at 48 to 72 hours, end of treatment, and follow-up with delafloxacin was 58%, 94%, and 100% vs 59%, 94%, and 100% with vancomycin/ aztreonam, respectively. “Baseline mean pain scores were 8, with scores of ~2.5 at [end of treatment] and 1 at [follow-up] for both treatment groups,” noted the investigators.


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“Baxdela monotherapy provided patients with rapid decrease in pain, as well as improvement in signs and symptoms and redness by 48 to 72 hours,” said Sue K. Cammarata, MD, Melinta Therapeutics' chief medical officer, in an interview with Infectious Disease Advisor. “Using one drug with IV and oral options provides treatment simplicity in complicated patients,” concluded Dr Cammarata.

Disclosures

Sue K. Cammarata, MD, Laura Lawrence, and Megan Quintas are employees of Melinta Therapeutics, Inc. The remaining authors have received either research grants or consulting fees from Melinta Therapeutics, Inc.

Reference

Giordano P, Pullman J, Lawrence L, Quintas M, Tseng C, Cammarata SK. Impact of delafloxacin (DLX) and vancomycin/aztreonam (VAN/AZ) on resolution of signs and symptoms of acute bacterial skin and skin structure infections (ABSSSI). Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Poster 1854.

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