Delafloxacin for the treatment of adult patients with community-acquired bacterial pneumonia

References

• Torres A, Cilloniz C, Niederman MS, et al. Pneumonia. Nat Rev Dis Primers. 2021 Apr 8;7(1):25.
   PubMed Web of Science ®Google Scholar
• Hirai J, Kinjo T, Koga T, et al. Clinical characteristics of community-acquired pneumonia due to Moraxella catarrhalis in adults: a retrospective single-centre study. BMC Infect Dis. 2020 Nov 10;20(1):821.
   PubMed Web of Science ®Google Scholar
• Woodhead M. Community-acquired pneumonia in Europe: causative pathogens and resistance patterns. Eur Respir J Suppl. 2002 Jul;20(Supplement 36):20s–27s.
   Google Scholar
• Morris DE, Cleary DW, Clarke SC. Secondary bacterial infections associated with influenza pandemics. Front Microbiol. 2017;8:1041.
   PubMed Web of Science ®Google Scholar
• Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45–e67.
   PubMed Web of Science ®Google Scholar
• Bassetti M, Della Siega P, Pecori D, et al. Delafloxacin for the treatment of respiratory and skin infections. Expert Opin Investig Drugs. 2015 Mar;24(3):433–442.
   PubMed Web of Science ®Google Scholar
• Remy JM, Tow-Keogh CA, McConnell TS, et al. Activity of delafloxacin against methicillin-resistant Staphylococcus aureus: resistance selection and characterization. J Antimicrob Chemother. 2012 Dec;67(12):2814–2820.
   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 Feb;55(2):649–658.
   PubMed Web of Science ®Google Scholar
• Hooper DC. Mode of action of fluoroquinolones. Drugs. 1999;58(Suppl 2):6–10.
   PubMed Web of Science ®Google Scholar
• Walker RC, Wright AJ. The fluoroquinolones. Mayo Clin Proc. 1991 Dec;66(12):1249–1259.
   PubMed Web of Science ®Google Scholar
• Jorgensen SCJ, Mercuro NJ, Davis SL, et al. Delafloxacin: place in therapy and review of microbiologic, clinical and pharmacologic properties. Infect Dis Ther. 2018 Jun;7(2):197–217.
   PubMed Web of Science ®Google Scholar
• Smith HJ, Nichol KA, Hoban DJ, et al. Dual activity of fluoroquinolones against Streptococcus pneumoniae: the facts behind the claims. J Antimicrob Chemother. 2002 Jun;49(6):893–895.
   PubMed Web of Science ®Google Scholar
• Koulenti D, Xu E, Mok IYS, et al. Novel antibiotics for multidrug-resistant gram-positive microorganisms. Microorganisms. 2019 Aug 18;7(8):270.
   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 Oct;60(10):6381–6385.
   PubMed Web of Science ®Google Scholar
• Cercenado E, Loras C, Cobos A, et al. In vitro activity of delafloxacin against highly levofloxacin-resistant invasive isolates of Streptococcus pneumoniae. Enferm Infect Microbiol Clin. 2020 Nov 12. DOI:https://doi.org/10.1016/j.eimc.2020.09.016
   Google Scholar
• Hipp M, Burckhardt I. In vitro activity of newer antimicrobials against penicillin non-susceptible strains of Streptococcus pneumoniae. Infect Drug Resist. 2019;12:1889–1893.
   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 Apr;61(4). DOI:https://doi.org/10.1128/AAC.02609-16
   Web of Science ®Google Scholar
• Saravolatz LD, Pawlak JM, Wegner C. Delafloxacin activity against Staphylococcus aureus with reduced susceptibility or resistance to methicillin, vancomycin, daptomycin or linezolid. J Antimicrob Chemother. 2020 Sep 1;75(9):2605–2608.
   PubMed Web of Science ®Google Scholar
• Hammerschlag MR, Roblin PM. The in vitro activity of a new fluoroquinolone, ABT-492, against recent clinical isolates of Chlamydia pneumoniae. J Antimicrob Chemother. 2004 Jul;54(1):281–282.
   PubMed Web of Science ®Google Scholar
• Nilius AM, Shen LL, Hensey-Rudloff D, et al. In vitro antibacterial potency and spectrum of ABT-492, a new fluoroquinolone. Antimicrob Agents Chemother. 2003 Oct;47(10):3260–3269.
   PubMed Web of Science ®Google Scholar
• McCurdy S, Nenninger A, Sheets A, et al. Efficacy of delafloxacin versus moxifloxacin against atypical bacterial respiratory pathogens in adults with community-acquired bacterial pneumonia (CABP): data from the Delafloxacin Phase 3 CABP Trial. Int J Infect Dis. 2020 Aug;97:374–379.
   PubMed Web of Science ®Google Scholar
• Almer LS, Hoffrage JB, Keller EL, et al. In vitro and bactericidal activities of ABT-492, a novel fluoroquinolone, against Gram-positive and Gram-negative organisms. Antimicrob Agents Chemother. 2004 Jul;48(7):2771–2777.
   PubMed Web of Science ®Google Scholar
• Goldstein EJ, Citron DM, Merriam CV, et al. In vitro activities of ABT-492, a new fluoroquinolone, against 155 aerobic and 171 anaerobic pathogens isolated from antral sinus puncture specimens from patients with sinusitis. Antimicrob Agents Chemother. 2003 Sep;47(9):3008–3011.
   PubMed Web of Science ®Google Scholar
• Harnett SJ, Fraise AP, Andrews JM, et al. Comparative study of the in vitro activity of a new fluoroquinolone, ABT-492. J Antimicrob Chemother. 2004 May;53(5):783–792.
   PubMed Web of Science ®Google Scholar
• McCurdy S, Keedy K, Lawrence L, et al. Efficacy of delafloxacin versus moxifloxacin against bacterial respiratory pathogens in adults with Community-Acquired Bacterial Pneumonia (CABP): microbiology results from the delafloxacin Phase 3 CABP Trial. Antimicrob Agents Chemother. 2020 Feb 21;64(3). DOI:https://doi.org/10.1128/AAC.01949-19.
   Google Scholar
• Waites KB, Crabb DM, Duffy LB. Comparative in vitro susceptibilities and bactericidal activities of investigational fluoroquinolone ABT-492 and other antimicrobial agents against human mycoplasmas and ureaplasmas. Antimicrob Agents Chemother. 2003 Dec;47(12):3973–3975.
   PubMed Web of Science ®Google Scholar
• Zhanel GG, Palatnick L, Nichol KA, et al. Antimicrobial resistance in respiratory tract Streptococcus pneumoniae isolates: results of the Canadian Respiratory Organism Susceptibility Study, 1997 to 2002. Antimicrob Agents Chemother. 2003 Jun;47(6):1867–1874.
   PubMed Web of Science ®Google Scholar
• Zhanel GG, Palatnick L, Nichol KA, et al. Antimicrobial resistance in Haemophilus influenzae and Moraxella catarrhalis respiratory tract isolates: results of the Canadian Respiratory Organism Susceptibility Study, 1997 to 2002. Antimicrob Agents Chemother. 2003 Jun;47(6):1875–1881.
   PubMed Web of Science ®Google Scholar
• Cho JC, Crotty MP, White BP, et al. What is old is new again: delafloxacin, a modern fluoroquinolone. Pharmacotherapy. 2018 Jan;38(1):108–121.
   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 Jan 1;38(1):39–52.
   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 Jan 1;38(1):53–65.
   PubMed Web of Science ®Google Scholar
• Mogle BT, Steele JM, Thomas SJ, et al. Clinical review of delafloxacin: a novel anionic fluoroquinolone. J Antimicrob Chemother. 2018 Jun 1;73(6):1439–1451.
   PubMed Web of Science ®Google Scholar
• Hoover R, Marbury TC, Preston RA, et al. Clinical pharmacology of delafloxacin in patients with hepatic impairment. J Clin Pharmacol. 2017 Mar;57(3):328–335.
   PubMed Web of Science ®Google Scholar
• Markham A. Delafloxacin: first global approval. Drugs. 2017 Sep;77(13):1481–1486.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Quofenix (R). Summary of product characteristics [ accessed 2021 Aug 14]. accessed: https://www.ema.europa.eu/en/documents/product-information/quofenix-epar-product-information_en.pdf
   Google Scholar
• Liapikou A, Cilloniz C, Palomeque A, et al. Emerging antibiotics for community-acquired pneumonia. Expert Opin Emerg Drugs. 2019 Dec;24(4):221–231.
   PubMed Web of Science ®Google Scholar
• Thabit AK, Crandon JL, Nicolau DP. Pharmacodynamic and pharmacokinetic profiling of delafloxacin in a murine lung model against community-acquired respiratory tract pathogens. Int J Antimicrob Agents. 2016 Nov;48(5):535–541.
   PubMed Web of Science ®Google Scholar
• McEwen A, Lawrence L, Hoover R, et al. Disposition, metabolism and mass balance of delafloxacin in healthy human volunteers following intravenous administration. Xenobiotica. 2015;45(12):1054–1062.
   PubMed Web of Science ®Google Scholar
• Righi E, Carnelutti A, Vena A, et al. Emerging treatment options for acute bacterial skin and skin structure infections: focus on intravenous delafloxacin. Infect Drug Resist. 2018;11:479–488.
   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 Jun;39(6):1182–1190.
   PubMed Web of Science ®Google Scholar
• Lepak AJ, Andes DR. In vivo pharmacodynamic target assessment of delafloxacin against staphylococcus aureus, streptococcus pneumoniae, and klebsiella pneumoniae in a murine lung infection model. Antimicrob Agents Chemother. 2016 Aug;60(8):4764–4769.
   PubMed Web of Science ®Google Scholar
• Andes D, Craig WA. Pharmacodynamics of the new fluoroquinolone gatifloxacin in murine thigh and lung infection models. Antimicrob Agents Chemother. 2002 Jun;46(6):1665–1670.
   PubMed Web of Science ®Google Scholar
• Andes D, Craig WA. Pharmacodynamics of the new des-f(6)-quinolone garenoxacin in a murine thigh infection model. Antimicrob Agents Chemother. 2003 Dec;47(12):3935–3941.
   PubMed Web of Science ®Google Scholar
• Forrest A, Nix DE, Ballow CH, et al. Pharmacodynamics of intravenous ciprofloxacin in seriously ill patients. Antimicrob Agents Chemother. 1993 May;37(5):1073–1081.
   PubMed Web of Science ®Google Scholar
• Horcajada JP, Salata RA, Alvarez-Sala R, et al. A Phase 3 study to compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP). Open Forum Infect Dis. 2020 Jan;7(1):ofz514.
   PubMed Web of Science ®Google Scholar
• McCurdy SP, Sheets AJ, Cammarata SK, et al. Serotype distribution and antimicrobial susceptibility of Streptococcus pneumoniae isolates from a Phase III community-acquired bacterial pneumonia (CABP) trial. JAC Antimicrob Resist. 2021 Jun;3(2):dlab057.
   PubMedGoogle Scholar
• Tillotson GS. FDA and the safe and appropriate antibiotic use of fluoroquinolones. Lancet Infect Dis. 2016 Mar;16(3):e11–2.
   PubMed Web of Science ®Google Scholar
• Mehlhorn AJ, Brown DA. Safety concerns with fluoroquinolones. Ann Pharmacother. 2007 Nov;41(11):1859–1866.
   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 and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016 Mar;71(3):821–829.
   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 Jan;30:67–73.
   PubMed Web of Science ®Google Scholar
• O’Riordan W, McManus A, Teras J, et al. A comparison of the efficacy and safety of intravenous followed by oral delafloxacin with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections: a Phase 3, Multinational, double-blind, randomized study. Clin Infect Dis. 2018 Aug 16;67(5):657–666.
   PubMed Web of Science ®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 Dec 1;72(12):3471–3480.
   PubMed Web of Science ®Google Scholar
• Firsov AA, Vostrov SN, Lubenko IY, et al. ABT492 and levofloxacin: comparison of their pharmacodynamics and their abilities to prevent the selection of resistant Staphylococcus aureus in an in vitro dynamic model. J Antimicrob Chemother. 2004 Jul;54(1):178–186.
   PubMed Web of Science ®Google Scholar
• Hermsen ED, Hovde LB, Konstantinides GN, et al. Mutant prevention concentrations of ABT-492, levofloxacin, moxifloxacin, and gatifloxacin against three common respiratory pathogens. Antimicrob Agents Chemother. 2005 Apr;49(4):1633–1635.
   PubMed Web of Science ®Google Scholar
• Jacoby GA. Mechanisms of resistance to quinolones. Clin Infect Dis. 2005 Jul 15;41(Suppl 2):S120–6.
   PubMed Web of Science ®Google Scholar