Delafloxacin: a novel fluoroquinolone with activity against methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa

References

• Van Bambeke F. Delafloxacin, a non-zwitterionic fluoroquinolone in Phase III of clinical development: evaluation of its pharmacology, pharmacokinetics, pharmacodynamics and clinical efficacy. Future Microbiol. 2015;10(7):1111–1123.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). About Antimicrobial Resistance. https://www.cdc.gov/drugresistance/about.html. Last updated April 6, 2017.
   Google Scholar
• Kocsis B, Domokos J, Szabo D. Chemical structure and pharmacokinetics of novel quinolone agents represented by avarofloxacin, delafloxacin, finafloxacin, zabofloxacin and nemonoxacin. Ann Clin Microbiol Antimicrob. 2016;15:34.
   PubMed Web of Science ®Google Scholar
• Baxdela® (delafloxacin) [package insert] Lincolnshire. IL: Melinta Therapeutics, Inc; 2017.
   Google Scholar
• Candel FJ, Peñuelas M. Delafloxacin: design, development and potential place in therapy. Drug Des Dev Ther. 2017;11:881–891.
   PubMed Web of Science ®Google Scholar
• Lemaire S, Tulkens PM, Van Bambeke F. Contrasting effects of acidic pH on the extracellular and intracellular activities of the anti-gram-positive fluoroquinolones moxifloxacin and delafloxacin against Staphylococcus aureus. Antimicrob Agents Chemother. 2011;55(2):649–658.
   PubMed Web of Science ®Google Scholar
• McCurdy S, Lawrence L, Quintas M, et al. In vitro activity of delafloxacin and microbiological response against fluoroquinolone-susceptible and nonsusceptible Staphylococcus aureus isolates from two phase 3 studies of acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2017;61(9):e00772–17.
   PubMed Web of Science ®Google Scholar
• Pfaller MA, Sader HS, Rhomberg PR, et al. In vitro activity of delafloxacin against contemporary bacterial pathogens from the United States and Europe, 2014. Antimicrob Agents Chemother. 2017;61(4):e02609–16.
   PubMed Web of Science ®Google Scholar
• Flamm RK, Rhomberg PR, Huband MD, et al. In vitro activity of delafloxacin tested against isolates of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Antimicrob Agents Chemother. 2016;60(10):6381–6385.
   PubMed Web of Science ®Google Scholar
• Soge OO, Salipante SJ, No D, et al. In vitro activity of delafloxacin against clinical Neisseria gonorrhoeae isolates and selection of gonococcal delafloxacin resistance. Antimicrob Agents Chemother. 2016;60(5):3106–3111.
   PubMed Web of Science ®Google Scholar
• Clinical and Laboratory Standards Institute. M100 – 26. Performance standards for antimicrobial susceptibility testing: 26th informational supplement. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
   Google Scholar
• EUCAST. 2016. Breakpoint tables for interpretation of MICs and zone diameters, version 6.0, January. http://www/eucast.org/clinical_breakpoints/. Accessed December 6, 2017.
   Google Scholar
• Hoover R, Marbury TC, Preston RA, et al. Clinical Pharmacology of delafloxacin in patients with hepatic impairment. J Clin Pharmacol. 2017;57(3):328–335.
   PubMed Web of Science ®Google Scholar
• Hoover R, Hunt T, Benedict M, et al. Safety, tolerability, and pharmacokinetic properties of intravenous delafloxacin after single and multiple doses in healthy volunteers. Clin Ther. 2016;38:53–65.
   PubMed Web of Science ®Google Scholar
• Hoover R, Hunt T, Benedict M, et al. Single and multiple ascending-dose studies of oral delafloxacin: effects of food, sex, and age. Clin Ther. 2016;38:39–52.
   PubMed Web of Science ®Google Scholar
• Paulson SK, Wood-Horrall RN, Hoover R, et al. The pharmacokinetics of the CYP3A substrate midazolam after steady-state dosing of delafloxacin. Clin Ther. 2017;39(6):1182–1190.
   PubMed Web of Science ®Google Scholar
• O’Riordan W, Mehra P, Manos P, et al. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015;30:67–73.
   PubMed Web of Science ®Google Scholar
• Kingsley J, Mehra P, Lawrence LE, et al. A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin ad skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016;71:821–829.
   PubMed Web of Science ®Google Scholar
• Cammarata S, Gardovskis J, Farley B, et al. Results of a global phase 3 study of delafloxacin (DLX) compared to vancomycin with aztreonam (VAN) in acute bacterial skin and skin structure infections (ABSSSI). Abstract presented at: ID Week Meeting; October 7–11, 2015; San Diego, CA.
   Google Scholar
• O’Riordan W, McManus A, Teras J, et al. A global phase 3 study of delafloxacin (DLX) compared to vancomycin/aztreonam (VAN/AZ) in patients with acute bacterial skin and skin structure infections (ABSSSI). Abstract presented at: ID Week Meeting; October 26–30, 2016; New Orleans, LA.
   Google Scholar
• Melinta Therapeutics, Inc. The Antibiotics Company. Baxdela (Delafloxacin): United States. http://melinta.com/pipeline/baxdela/. Accessed December 28 2017.
   Google Scholar
• Pullman J, Gardovskis J, Farley B, et al. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017;72:3471–3480.
   PubMed Web of Science ®Google Scholar
• Litwin JS, Benedict MS, Thorn MD, et al. a thorough QT study to evaluate the effects of therapeutic and subtherapeutic doses of delafloxacin on cardiac reploarization. Antimicrob Agents and Chemother. 2015;59(6):3469–3473.
   PubMed Web of Science ®Google Scholar
• Jeon N, Staley B, Klinker KP, et al. Acute kidney injury risk associated with piperacillin/tazobactam compared with cefepime during vancomycin therapy in hospitalized patients: a cohort study stratified by baseline kidney function. Int J Antimicrob Agents. 2017;50(1):63–67.
   PubMed Web of Science ®Google Scholar
• Navalkele B, Pogue JM, Karino S, et al. Risk of acute kidney injury in patients on concomitant vancomycin and piperacillin-tazobactam compared to those on vancomycin and cefepime. Clin Infect Dis. 2017;64(2):116–123.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. https://www.fda.gov/Drugs/DrugSafety/ucm500143.htm. Last updated October 12, 2017.
   Google Scholar
• Levaquin® (levofloxacin) [package insert] Lake Forest, IL: Hospira, Inc. 2008.
   Google Scholar
• Melinta Therapeutics. Melinta Therapeutics and Hartford Hospital Demonstrate Delafloxacin’s Potent in-vitro Activity Against Complicated Urinary Tract Infection Pathogens. http://melinta.com/melinta-therapeutics-and-hartford-hospital-demonstrate-delafloxacins-potent-in-vitro-activity-against-complicated-urinary-tract-infection-pathogens/. Accessed January 1, 2018.
   Google Scholar
• Morrow BJ, He W, Amsler KM, et al. In vitro antibacterial activities of JNJ-Q2, a new broad-spectrum fluoroquinolone. Antimicrob Agents Chemother. 2010;54(5):1955–1964.
   PubMed Web of Science ®Google Scholar
• Biedenbach DJ, Turner LL, Jones RN, et al. Activity of JNJ-Q2, a novel fluoroquinolone, tested against Neisseria gonorrhoeae, including ciprofloxacin-resistant strains. Diagn Microbol Infect Dis. 2012;74(2):204–206.
   PubMed Web of Science ®Google Scholar
• Patel H, Anderson A, Vente A, et al. Human pharmacokinetics and safety profile of finafloxacin a new fluoroquinolone antibiotic in healthy volunteers. Antimicrob Agents Chemother. 2011;55:4386–4393.
   PubMed Web of Science ®Google Scholar
• Buissonniere A, Bergey B, Megraud F, et al. In: antimicrobial activity of finafloxacin (FIN) against Helicobacter pylori in vitro and in vivo. Proceedings of the 48th interscience conference of antimicrobial agents and chemotherapy, Washington, USA, October 25–28, 2008.
   Google Scholar
• Adam HJ, Laing NM, King CR, et al. In vitro activity of nemofloxacin a novel nonfluorinated quinolone against 2440 clinical isolates. Antimicrob Agents Chemother. 2009;53:4915–4920.
   PubMed Web of Science ®Google Scholar
• Barry AL, Fucgs PC, Brown SD. In vitro activities of three non-fluorinated quinolones against representative bacterial isolates. J Antimicrob Chemother. 2009;64:1923–1927.
   Google Scholar
• Chen YH, Liu CY, Lu JJ, et al. In vitro activity of nemonoxacin (TG-873870) a novel non-fluorinated quinolone against clinical isolates of Staphylococcus aureus and enterococci and Streptococcus pneumoniae with various resistance phenotypes in Taiwan. J Antimicrob Chemother. 2009;64:1226–1229.
   PubMed Web of Science ®Google Scholar
• Park HS, Kim HJ, Seol MJ, et al. In vitro and in vivo antibacterial activities of DW-224a, a new fluoronaphthyridone. Antimicrob Agents Chemother. 2006;50(6):2261–2264.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). Antibiotic-Resistant Gonorrhea. https://www.cdc.gov/std/gonorrhea/arg/default.htm. Last updated December 6, 2017.
   Google Scholar
• Tacconelli E, Carrara E, Savoldi A, et al. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2017. DOI:10.1016/S1473-3099(17)30753-3.
   Web of Science ®Google Scholar
• Melinta Therapeutics. Melinta Therapeutics Ceases Phase 3 PROCEEDING Study. http://melinta.com/melinta-therapeutics-ceases-phase-3-proceeding-study/. Accessed January 1, 2018.
   Google Scholar