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SAN FRANCISCO — Treatment with intravenous (IV) and oral delafloxacin, a fluoroquinolone antibiotic with gram-negative and gram-positive activity, was comparable to vancomycin/aztreonam in improving clinical signs and symptoms in acute bacterial and skin structure infections (ABSSSI), according to findings of a multicenter randomized trial presented at IDWeek 2018, held October 3 to 7, 2018, in San Francisco, California.
Delafloxacin is approved for treatment of ABSSSI and showed noninferiority to vancomycin/aztreonam in a previous phase 3 trial. In this study, the researchers evaluated clinical signs and symptoms of skin infection, and also measured lesion size. A total of 850 patients with ABSSSI were randomly assigned in a 1:1 ratio to receive either delafloxacin monotherapy (300 mg/12 hours IV with a switch to oral 450 mg/12 hours) or vancomycin (15 mg/kg actual body weight) with aztreonam for 5 to 14 days. Patients who achieved a complete resolution of signs and symptoms of skin infection were considered to be cured. Assessments were conducted at baseline, over the course of infection, at the completion of treatment, and at follow-up on day 14 and late follow-up on days 21 to 28.
In both groups, the mean number of treatment days was 7. Patients in both study groups had experienced comparable improvements in signs and symptoms of skin infection, with complete resolution at the end of treatment in 42% of patients receiving delafloxacin vs 45% patients receiving vancomycin/aztreonam; 58% vs 60%, respectively, at follow-up; and 68% vs 71%, respectively, at late follow-up. Reduction of erythema was comparable in both groups, with a mean reduction of 98% in patients receiving delafloxacin vs 97% patients receiving vancomycin/aztreonam at long-term follow-up.
“Treatment with [delafloxacin and vancomycin/aztreonam] provided equally rapid improvement in clinical signs and symptoms in ABSSSI with comparable reductions in [signs and symptoms of skin infection], lesion size and pain score,” the study authors concluded.
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Pullman J, O’Riordan W, Lawrence L, Quintas M, Tseng C, Cammarata SK. Resolution of signs and symptoms (S&S) of acute bacterial skin and skin structure infections (ABSSSI) with Delafloxacin (DLX) IV/Oral Therapy. Presented at: IDWeek 2018; October 3-7, 2018; San Francisco, CA. Abstract 2378.