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Delafloxacin
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Rekha Pai Mangalore, Jason Kwong, M. Lindsay Grayson
Delafloxacin (Baxdela) is currently undergoing phase III clinical trials for treatment of complicated acute bacterial skin and skin structure infections (ABSSSI) and phase II trials for treatment of hospital-treated community-acquired bacterial pneumonia (hCABP). It is currently available to registered users in both intravenous (i.v.) and oral (tablet) formulations. It has been designated as a qualified infectious diseases product (QIDP) by the US FDA.
Acute bacterial skin and soft tissue infections: new drugs in ID armamentarium
Published in Journal of Community Hospital Internal Medicine Perspectives, 2019
Raghavendra Tirupathi, Swetha Areti, Sohail A. Salim, Venkatraman Palabindala, Nageshwar Jonnalagadda
New-generation anionic quinolone with spectrum of activity against various gram-positive and gram-negative pathogens, including Staphylococcus aureus (methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] strains), S. haemolyticus, S. lugdunensis, Streptococcus pyogenes, S. agalactiae, S. anginosus group, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, and Pseudomonas aeruginosa. Baxdela exerts antibacterial activity through inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes. The drug is available in both IV and oral formulations and has 60% oral bioavailability. No dose adjustments are needed for body weight, hepatic impairment, or mild-to-moderate renal impairment. It can be used as a step-down therapy at discharge. The gram-negative and anti-pseudomonal coverage makes it attractive as a single agent option for diabetic foot and other poly-microbial infections. FDA black box warnings for quinolone apply to Delafloxacin with adverse effects including C. difficile infection, tendon rupture, QT prolongation, and effects on glucose homeostasis [14–16]. However, most common side effects include nausea, vomiting and diarrhea.
Delafloxacin: a novel fluoroquinolone with activity against methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa
Published in Expert Review of Anti-infective Therapy, 2018
Eric R. Ocheretyaner, Tae Eun Park
In June 2017, delafloxacin (Baxdela™; Melinta Therapeutics, Inc.) received approval by the US Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) in adults caused by designated susceptible bacteria [4]. The recommended dose of delafloxacin for ABSSSIs is 300 mg intravenous (IV) infusion over 1 h every 12 h or 450 mg orally every 12 h for a total duration of 5–14 days. At the discretion of the provider, patients may be initiated on IV therapy and transitioned to oral therapy to complete the course of treatment. Patients with renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m2) require a modification in the IV dose only (Table 1). Currently, there is insufficient information to provide a dosing recommendation for patients that are receiving hemodialysis [4]. The objective of this article is to review the pharmacological profile of delafloxacin as well as discuss the currently available clinical trial data.
Developments on antibiotics for multidrug resistant bacterial Gram-negative infections
Published in Expert Review of Anti-infective Therapy, 2019
Georgios L. Voulgaris, Maria L. Voulgari, Matthew E. Falagas
Delafloxacin (marketed as Baxdela in the U.S.) is a novel synthetic fluoroquinolone, which was approved by the FDA for the treatment of acute bacterial skin and skin structure infections (ABSSSI), caused by several Gram-positive and Gram-negative bacteria, and was developed by Melinta Therapeutics, Inc. Like other fluoroquinolones, delafloxacin can be administered either orally or intravenously, allowing to switch from intravenous to oral therapy, which potentially reduces the duration of the hospitalization [104,105]. According to the FDA approval, the recommended delafloxacin dosage should be 300 mg administered intravenously over 60 min, or 450 mg administered orally every 12 h for no more than 14 days [106] (Table 2).