Background. Delafloxacin is an IV and oral investigational anionic fluoroquinolone with a full spectrum of activity being developed for the potential of treating a variety of infections including ABSSSI. Methods. Multicenter, randomized, double-blind trial of adults with major abscesses, cellulitis, wound or burn infections with ≥75 cm2 erythema and ≥2 systemic signs. Patients were randomized 1:1 to receive BID DLX 300 mg IV for 3 days with a switch to 450 mg oral, or recommended VAN 15 mg/kg IV with AZ for 5–14 days. The primary endpoint was response at 48–72 hours. A secondary endpoint was investigator-assessed response based on complete resolution of signs and symptoms (Cure) at follow-up (FU), Day 14 ± 1, and late follow-up (LFU), Day 21–28. Clinical success was defined as Cure + Improved (no further antibiotics were needed per investigator assessment). Results. A total of 850 patients were randomized, of whom 63% were male with mean age 50.7 years. Average lesion size was 353 cm2; 48% of patients had cellulitis, 25% abscesses, 26% wounds, and 1% burn infections. A total of 552 (65%) patients had pathogens identified at baseline. Efficacy data for the intent-to-treat (ITT) population are presented below: In the micro-evaluable population, DLX was comparable to VAN in eradication of methicillin resistant Staphylococcus aureus (MRSA), 96.0% (48/50) versus 97.0% (32/33) at FU. At least 43.6% DLX and 39.3% VAN patients had at least one treatment-emergent adverse event. The most common DLX events were diarrhea and nausea, which were mild and did not lead to discontinuation. There were similar rates between DLX and VAN of study treatment discontinuations (7.3% versus 8.9%) and serious adverse events (3.8% versus 4.0%); however, the only 2 deaths in the study occurred in VAN/AZ. Conclusion. IV/oral DLX was comparable to IV VAN/AZ in treatment of ABSSSI, and DLX was also comparable to VAN in treating patients with MRSA. DLX appears well tolerated with low discontinuation rates. Disclosures. W. O' Riordan, Melinta Therapeutics: Investigator, Research support A. Mc Manus, Melinta Therapeutics: Investigator, Research support J. Teras, Melinta Therapeutics: Investigator, Research support I. Poromanski, Melinta Therapeutics: Investigator, Research support M. Cruz Saldariagga, Melinta Therapeutics: Investigator, Research support M. Quintas, Melinta Therapeutics, Inc.: Employee, Salary L. Lawrence, Melinta Therapeutics, Inc.: Employee, Salary S. Cammarata, Melinta Therapeutics: Employee, Salary
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Riordan et al. (2016) studied this question.