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SAN DIEGO – Oral and intravenous (IV) administration of fixed-dose delafloxacin (Baxdela™, Melinta Therapeutics, Inc.) provides comparable efficacy and safety outcomes to vancomycin/aztreonam in patients with acute bacterial skin and skin structure infection (ABSSSI) with gram-positive pathogens and methicillin-resistant Staphylococcus aureus (MRSA), according to results from 2 randomized, double-blind trials presented at IDWeek 2017.
Investigators evaluated outcomes in patients with ABSSSI who received delafloxacin 300 mg IV every 12 hours (in patients with gram-positive pathogens), or delafloxacin 300 mg IV every 12 hours for 3 days with a mandatory blinded switch to oral delafloxacin 450 mg every 12 hours (in patients with gram-negative pathogens), or vancomycin 15 mg/kg IV (actual body weight) with aztreonam between 5 to 14 days. A total of 1042 patients enrolled in the studies had a pathogen at baseline. Approximately 95% (n=987) of patients had a baseline gram-positive pathogen, whereas 14% had a mixed infection. S aureus was the most frequent isolate.
Similar treatment-emergent adverse events were reported between the delafloxacin (45.1%) and vancomycin/aztreonam (47.7%) groups. Only 0.8% of patients taking delafloxacin discontinued therapy because of treatment-emergent adverse events compared with 2.4% of patients receiving vancomycin/aztreonam. Investigators found that the most frequent treatment-emergent adverse events were associated with the gastrointestinal system and included nausea (6.1% for delafloxacin and 4.3% vancomycin/aztreonam) and diarrhea (6.1% for delafloxacin and 2.0% for vancomycin/aztreonam). Based on the findings, the investigators concluded that the administration of delafloxacin monotherapy is effective and features a favorable tolerability profile for the management of patients with ABSSSI with MRSA.
“Baxdela was comparable to vancomycin in safety and clinical outcomes in patients who had infections due to gram-positive bacteria, the most commonly identified bacteria in skin infections. Baxdela’s IV and oral options coupled with its activity against MRSA will allow physicians to consider an easy hospital-to-home transition,” stated Sue K. Cammarata, MD, Melinta Therapeutics’ chief medical officer, in an interview with Infectious Disease Advisor.
Sue K. Cammarata, MD, is the chief medical officer of Melinta Therapeutics, Inc. All other authors have received either research grants, consulting fees, or are employed by Melinta Therapeutics, Inc. All full listing of disclosures can be viewed here.
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Overcash S, O’Riordan W, Lawrence L, McCurdy SP, Tseng C, Cammarata SK. Outcomes with IV/oral delafloxacin (DLX) compared to vancomycin/aztreonam (VAN/AZ) in treatment of patients (pts) with acute bacterial skin and skin structure infections (ABSSSI) and gram-positive (GP) pathogens. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, CA. Poster 1857.