Emerging treatment options for acute bacterial skin and skin structure infections: focus on intravenous delafloxacin

References

• Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10–e52.
   PubMed Web of Science ®Google Scholar
• Hersh AL, Chambers HF, Maselli JH, Gonzales R. National trends in ambulatory visits and antibiotic prescribing for skin and soft-tissue infections. Arch Intern Med. 2008;168(14):1585–1591.
   PubMed Web of Science ®Google Scholar
• Moran GJ, Krishnadasan A, Gorwitz RJ, et al; EMERGEncy ID Net Study Group. Methicillin-resistant Staphylococcus aureus infections among patients in the emergency department. N Engl J Med. 2006;355(7):666–674.
   PubMed Web of Science ®Google Scholar
• Pallin DJ, Egan DJ, Pelletier AJ, Espinola JA, Hooper DC, Camargo CA Jr. Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med. 2008;51(3):291–298.
   PubMed Web of Science ®Google Scholar
• Moet GJ, Jones RN, Biedenbach DJ, Stilwell MG, Fritsche TR. Contemporary causes of skin and soft tissue infections in North America, Latin America, and Europe: report from the SENTRY Antimicrobial Surveillance Program (1998–2004). Diagn Microbiol Infect Dis. 2007;57(1):7–13.
   PubMed Web of Science ®Google Scholar
• Bassetti M, Nicco E, Mikulska M. Why is community-associated MRSA spreading across the world and how will it change clinical practice? Int J Antimicrob Agents. 2009;34(Suppl 1):S15–S19.
   PubMedGoogle Scholar
• European Centre for Disease Prevention and Control, ECDC. Antimicrobial resistance surveillance in Europe 2016. Available from: https://ecdc.europa.eu/en/antimicrobial-resistance/surveillance-and-disease-data. Acccessed November 30, 2017.
   Google Scholar
• Kluytmans-Vandenbergh MF, Kluytmans JA. Community-acquired methicillin-resistant Staphylococcus aureus: current perspectives. Clin Microbiol Infect. 2006;12(Suppl 1):9–15.
   PubMedGoogle Scholar
• David MZ, Daum RS. Community-associated methicillin-resistant Staphylococcus aureus: epidemiology and clinical consequences of an emerging epidemic. Clin Microbiol Rev. 2010;23(3):616–687.
   PubMed Web of Science ®Google Scholar
• Frazee BW, Lynn J, Charlebois ED, Lambert L, Lowery D, Perdreau-Remington F. High prevalence of methicillin-resistant Staphylococcus aureus in emergency department skin and soft tissue infections. Ann Emerg Med. 2005;45(3):311–320.
   PubMed Web of Science ®Google Scholar
• Miller LG, Quan C, Shay A, et al. A prospective investigation of outcomes after hospital discharge for endemic, community-acquired methicillin-resistant and -susceptible Staphylococcus aureus skin infection. Clin Infect Dis. 2007;44(4):483–492.
   PubMed Web of Science ®Google Scholar
• Edelsberg J, Berger A, Weber DJ, Mallick R, Kuznik A, Oster G. Clinical and economic consequences of failure of initial antibiotic therapy for hospitalized patients with complicated skin and skin-structure infections. Infect Control Hosp Epidemiol. 2008;29(2):160–169.
   PubMed Web of Science ®Google Scholar
• Bassetti M, Righi E, Carnelutti A. New therapeutic options for skin and soft tissue infections. Curr Opin Infect Dis. 2016;29(2):99–108.
   PubMed Web of Science ®Google Scholar
• Stenstrom R, Grafstein E, Romney M, et al. Prevalence of and risk factors for methicillin-resistant Staphylococcus aureus skin and soft tissue infection in a Canadian emergency department. CJEM. 2009;11(5):430–438.
   PubMedGoogle Scholar
• Cadena J, Richardson AM, Frei CR. Risk factors for methicillin-resistant Staphylococcus aureus skin and soft tissue infection in MRSA-colonized patients discharged from a Veterans Affairs hospital. Epidemiol Infect. 2016;144(3):647–651.
   PubMed Web of Science ®Google Scholar
• Dryden M, Andrasevic AT, Bassetti M, et al. A European survey of antibiotic management of methicillin-resistant Staphylococcus aureus infection: current clinical opinion and practice. Clin Microbiol Infect. 2010;16(Suppl 1):3–30.
   PubMed Web of Science ®Google Scholar
• Dryden M, Andrasevic AT, Bassetti M, et al. Managing skin and soft-tissue infection and nosocomial pneumonia caused by MRSA: a 2014 follow-up survey. Int J Antimicrob Agents. 2015;45(Suppl 1):S1–S14.
   PubMedGoogle Scholar
• Brink AJ. Does resistance in severe infections caused by methicillin-resistant Staphylococcus aureus give you the ‘creeps’? Curr Opin Crit Care. 2012;18(5):451–459.
   PubMed Web of Science ®Google Scholar
• Kim SH, Kim KH, Kim HB, et al. Outcome of vancomycin treatment in patients with methicillin-susceptible Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2008;52(1):192–197.
   PubMed Web of Science ®Google Scholar
• Stryjewski ME, Szczech LA, Benjamin DK Jr, et al. Use of vancomycin or first-generation cephalosporins for the treatment of hemodialysis-dependent patients with methicillin-susceptible Staphylococcus aureus bacteremia. Clin Infect Dis. 2007;44(2):190–196.
   PubMed Web of Science ®Google Scholar
• Ye ZK, Li C, Zhai SD. Guidelines for therapeutic drug monitoring of vancomycin: a systematic review. PLoS One 2014;9(6):e99044.
   PubMed Web of Science ®Google Scholar
• Van Bambeke F, Michot JM, Van Eldere J, Tulkens PM. Quinolones in 2005: an update. Clin Microbiol Infect. 2005;11(4):256–280.
   PubMed Web of Science ®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(1):34.
   PubMedGoogle Scholar
• De Souza MV. New fluoroquinolones: a class of potent antibiotics. Mini Rev Med Chem. 2005;5(11):1009–1017.
   PubMed Web of Science ®Google Scholar
• Piddock LJV. Fluoroquinolone resistance. BMJ. 1998;317(7165):1029–1030.
   PubMed Web of Science ®Google Scholar
• Walsh CT, Wencewicz TA. Prospects for new antibiotics: a molecule-centered perspective. J Antibiot (Tokyo). 2014;67(1):7–22.
   PubMed Web of Science ®Google Scholar
• Remy JM, Tow-Keogh CA, McConnell TS, Dalton JM, Devito JA. Activity of delafloxacin against methicillin-resistant Staphylococcus aureus: resistance selection and characterization. J Antimicrob Chemother. 2012;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;55(2):649–658.
   PubMed Web of Science ®Google Scholar
• Aldred KJ, Kerns RJ, Osheroff N. Mechanism of quinolone action and resistance. Biochem. 2014;53(10):1565–1574.
   PubMed Web of Science ®Google Scholar
• Harnett SJ, Fraise AP, Andrews JM, Jevons G, Brenwald NP, Wise R. Comparative study of the in vitro activity of a new fluoroquinolone, ABT-492. J Antimicrob Chemother. 2004;53(5):783–792.
   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;47(10):3260–3269.
   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
• Almer LS, Hoffrage JB, Keller EL, Flamm RK, Shortridge VD. In vitro and bactericidal activities of ABT-492, a novel fluoroquinolone, against Gram-positive and Gram-negative organisms. Antimicrob Agents Chemother. 2004;48(7):2771–2777.
   PubMed Web of Science ®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;47(12):3973–3975.
   PubMed Web of Science ®Google Scholar
• Soge OO, Salipante SJ, No D, Duffy E, Roberts MC. 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
• 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
• So W, Crandon JL, Nicolau DP. Effects of urine matrix and pH on the potency of delafloxacin and ciprofloxacin against urogenic Escherichia coli and Klebsiella pneumoniae. J Urol. 2015;194(2):563–570.
   PubMed Web of Science ®Google Scholar
• Bauer J, Siala W, Tulkens PM, Van Bambeke F. A combined pharmacodynamic quantitative and qualitative model reveals the potent activity of daptomycin and delafloxacin against Staphylococcus aureus biofilms. Antimicrob Agents Chemother. 2013;57(6):2726–2337.
   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(1):53–65.
   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
• Delafloxacin prescribing information. Available from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf. Accessed December 10, 2017.
   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(1):39–52.
   PubMed Web of Science ®Google Scholar
• Hoover R, Lawrence L, Smith C, Longcor J. Pharmacokinetics (PK) of delafloxacin in patients with varying degrees of renal impairment. Presented at: 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 10–13, 2013; CO, USA. Abstract A-017E.
   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
• Paulson SK, Wood-Horrall RN, Hoover R, Quintas M, Lawrence LE, Cammarata SK. 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
• Lepak AJ, Andes DR. In vivo pharmacodynamic target assessment of delafloxacin against Staphylococcus aureus, Streptococcus pneumoniae and Klebsiella pneumoniae in the murine lung infection model. Antimicrob Agents Chemother. 2016;60(8):4764–4769.
   PubMed Web of Science ®Google Scholar
• Burak E, Bortolon E, Molstad D, et al. Pharmacokinetics and pharmacodynamics of delafloxacin in S. aureus murine thigh infection models. Presented at: 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 12–15, 2009; CA, USA. Poster A1–1941.
   Google Scholar
• O’Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. 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 and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016;71(3):821–829.
   PubMed Web of Science ®Google Scholar
• Melinta Therapeutics, Inc. A phase 3, multicenter, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of delafloxacin compared with vancomycin plus aztreonam in patients with acute bacterial skin and skin structure infections. Available from: https://clinicaltrials.gov/ct2/show/NCT01811732. NML Identifier: NCT01811732. Accessed December 10, 2017.
   Google Scholar
• Melinta Therapeutics, Inc. A phase 3, multicenter, randomized, double-blind, active controlled study to evaluate the efficacy and safety of IV and oral delafloxacin compared with vancomycin plus aztreonam in patients with acute bacterial skin and skin structure infections. Available from: https://clinicaltrials.gov/ct2/show/NCT01984684. NML Identifier: NCT01984684. Accessed December 10, 2017.
   Google Scholar
• O’Riordan W, Overcash S, Lawrence L, McCurdy SP, Tseng C, Cammarata SK. Outcomes with IV/oral delafloxacin compared to vancomycin/aztreonam in treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) and gram-negative pathogens. Presented at: IDWeek 2017; San Diego, CA, USA. Poster 1856.
   Google Scholar
• Overcash S, O’Riordan W, Lawrence L, McCurdy SP, Tseng C, Cammarata SK. Outcomes with IV/oral delafloxacin compared to vancomycin/aztreonam in treatment of patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Gram-positive pathogens. Presented at: IDWeek 2017; San Diego, CA, USA. Poster 1857.
   Google Scholar
• Longcor J, Hopkins S, Wikler M, Lawrence L. A phase 2 safety and efficacy study of oral delafloxacin in subjects with acute bacterial exacerbation of chronic bronchitis (ABECB). Presented at: ID Week 2012; San Diego, CA, USA.
   Google Scholar
• Melinta Therapeutics, Inc. A phase 3, multicenter, randomized, double-blind, comparator-controlled study to evaluate the safety and efficacy of intravenous to oral delafloxacin in adult subjects with community-acquired bacterial pneumonia. Available from: https://clinicaltrials.gov/ct2/show/NCT02679573. NML Identifier: NCT02679573. Accessed December 10, 2017.
   Google Scholar
• Corey GA, Hooper D, Lodise TP, Tseng C, Cammarata SK. Comparison of safety profile of delafloxacin versus vancomycin/aztreonam in the treatment of patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI): integrated safety findings from two phase III studies. Presented at: IDWeek 2017; San Diego, CA, USA. Poster 1858.
   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(12):3471–3480.
   PubMed Web of Science ®Google Scholar
• Melinta Therapeutics. Assessment of phototoxicity potential of delafloxacin in healthy male and female subjects: a Phase 1 study. Presented at: 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 17–21, 2015; CA, USA. Abstract F-1198A.
   Google Scholar
• Litwin JS, Benedict MS, Thorn MD, Lawrence LE, Cammarata SK, Sun E. A thorough QT study to evaluate the effects of therapeutic and supratherapeutic doses of delafloxacin on cardiac repolarization. Antimicrob Agents Chemother. 2015;59(6):3469–3473.
   PubMed Web of Science ®Google Scholar
• Lipsky BA, Giordano P, Choudhri S, Song J. Treating diabetic foot infections with sequential intravenous to oral moxifloxacin compared with piperacillin-tazobactam/amoxicillin-clavulanate. J Antimicrob Chemother. 2007;60(2):370–376.
   PubMed Web of Science ®Google Scholar
• Majcher-Peszynska J, Sass M, Schipper S, et al; Moxifloxacin-DFI Study Group. Pharmacokinetics and penetration of moxifloxacin into infected diabetic foot tissue in a large diabetic patient cohort. Eur J Clin Pharmacol. 2011;67(2):135–142.
   PubMed Web of Science ®Google Scholar
• Rimmele T, Boselli E, Breilh D, et al. Diffusion of levofloxacin into bone and synovial tissues. J Antimicrob Chemother. 2004;53(3):533–535.
   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;48(5):535–541.
   PubMed Web of Science ®Google Scholar
• Charalabopoulos K, Karachalios G, Baltogiannis D, Charalabopoulos A, Giannakopoulos X, Sofikitis N. Penetration of antimicrobial agents into the prostate. Chemotherapy. 2003;49(6):269–279.
   PubMed Web of Science ®Google Scholar
• Malangoni MA, Song J, Herrington J, Choudhri S, Pertel P. Randomized controlled trial of moxifloxacin compared with piperacillin–tazobactam and amoxicillin–clavulanate for the treatment of complicated intra-abdominal infections. Ann Surg. 2006;244(2):204–211.
   PubMed Web of Science ®Google Scholar