According to a new study, new phase 3 trials were conducted for observing the treatments for skin infection. Delafloxacin is non-inferior to vancomycin plus aztreonam for treating acute bacterial skin and skin-structure infections (ABSSSI). Delafloxacin offers the potential for the treatment of infections caused by Gram-positive pathogens including MRSA and Gram-negative pathogens, without the need for combination therapy. This study was published in the Journal of Antimicrobial Chemotherapy.
The U.S. Food and Drug Administration approved delafloxacin for treating ABSSSI this June. Sold as Baxdela, the drug is a quinolone, but has a different size, shape and charge profile from other medications in this class, Dr. Cammarata and her colleagues note, making it “highly effective” and especially active against Gram-positive bacteria. The trial included 660 patients randomly assigned to intravenous delafloxacin 300 mg or vancomycin 15 mg/kg plus aztreonam 2 g, given twice daily for five to 14 days.
Intention-to-treat analysis found a similar objective response rate, around 80%, in both groups 48 to 72 hours after treatment. At follow-up, on day 14 of treatment, 52% of patients on delafloxacin and 50.5% of those on vancomycin/aztreonam were cured according to investigator assessment. At late-follow-up, on days 21-28, investigator-assessed cure rates were 70.4% and 66.6%, respectively. The rate of MRSA eradication was 100% with delafloxacin and 98.5% with vancomycin/aztreonam.
While treatment-emergent adverse events (TEAEs) were similar between the groups, TEAEs leading to treatment discontinuation were higher with vancomycin/aztreonam (4.3% vs. 0.9%). The researchers conclude: “With both intravenous and oral formulations, delafloxacin is appropriate for the treatment of diverse skin infection types due to Gram-positive and -negative bacteria, including patients with MRSA.”