Real-World Evidence of Efficacy and Safety of Levonadifloxacin (Oral and IV) in the Management of Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Findings of a Retrospective, Multi-Center Study

Abstract

BackgroundAntimicrobial resistance by bacteria poses a substantial threat to the success in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Levonadifloxacin is a novel benzoquinolizine subclass of quinolone which has a broad spectrum of activity, available in both oral and intravenous formulations for the treatment of skin structure infections caused by Gram-positive pathogens including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methodsThis prescription event monitoring study captured data of 227 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of ABSSSI. Study outcomes were a clinical and microbial success at the end of therapy and safety was assessed based on adverse events reported. ResultsOne hundred and forty patients received IV levonadifloxacin therapy, 76 patients received oral alalevonadifloxacin, and 11 received IV followed by oral therapy. The mean duration of therapy was 7.3 days. Out of 227 patients, MRSA isolates were identified in 79 patients. Clinical success rates with oral, IV, and IV followed by oral levonadifloxacin therapy were 97.3%, 97.8%, and 100% respectively. The overall microbial success rate was 99.2% and only two patients reported two adverse events. ConclusionsThe excellent safety and efficacy profile of levonadifloxacin on oral and/or intravenous therapy, makes it a desirable treatment modality for management of ABSSSI. Unique features of levonadifloxacin such as availability of both IV and oral form, minimal drug-drug interactions, exemption from dosage adjustment in renal and hepatic impaired patients and a broad spectrum of coverage, makes it a suitable agent meeting several unmet clinical needs in contemporary patients.

Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile?

“…The episode was mild, subsequently resolved, and was not directly associated with a potential Clostridium difficile infection. There were no serious AEs reported in the patient records, nor was levonadifloxacin therapy discontinued due to AEs [ 321 ].…”

“…Alalevonadifloxacin was found not to affect the baseline and placebo-corrected QTcF, QRS, or PR interval [ 341 ]. Furthermore, clinically indicated doses of 1000 mg are not anticipated to impact cardiac conduction or repolarization, except for a potential temporary increase in heart rate by a maximum of 14.4 beats per minute, which seems clinically negligible [ 321 , 341 ]. Therefore, levonadifloxacin constitutes a viable substitute for antibiotics that prolong the QT interval, including macrolides and other FQs.…”