Delafloxacin an effective option for acute bacterial skin infections

By Reuters Staff

NEW YORK (Reuters Health) - Delafloxacin is non-inferior to vancomycin plus aztreonam for treating acute bacterial skin and skin-structure infections (ABSSSI), according to a new phase 3 trial.

“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,” Dr. Sue Cammarata of Melinta Therapeutics in Lincolnshire, Illinois, and colleagues state in their report, online October 5 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.”

SOURCE: http://bit.ly/2i83X8B

J Antimicrob Chemother 2017.

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