Clinical and pharmacokinetic drug evaluation of delafloxacin for the treatment of acute bacterial skin and skin structure infections

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 Diseases: an Offl Pub Infectious Dis Soc Am. 2014 Jul 15;59(2):e10–52. PubMed PMID: 24973422. DOI:10.1093/cid/ciu444
   PubMed Web of Science ®Google Scholar
• FDA guidelines for ABSSI drug development. cited May 2. http://www.fda.gov/dowloads/Drugs/Guidances/ucm071185.pdf
   Google Scholar
• Dryden MS. Complicated skin and soft tissue infection. J Antimicrob Chemother. 2010 Nov;65(Suppl 3):iii35–44. PubMed PMID: 20876627. DOI:10.1093/jac/dkq302
   PubMed Web of Science ®Google Scholar
• Pallin DJ, Egan DJ, Pelletier AJ, et al. 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 Mar;51(3):291–298. PubMed PMID: 18222564. DOI:10.1016/j.annemergmed.2007.12.004
   PubMed Web of Science ®Google Scholar
• Edelsberg J, Taneja C, Zervos M, et al. Trends in US hospital admissions for skin and soft tissue infections. Emerg Infect Dis. 2009 Sep;15(9):1516–1518. PubMed PMID: 19788830; PubMed Central PMCID: PMC2819854. DOI:10.3201/eid1509.081228
   PubMed Web of Science ®Google Scholar
• Moet GJ, Jones RN, Biedenbach DJ, et al. 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 Jan;57(1):7–13. PubMed PMID: 17059876. DOI:10.1016/j.diagmicrobio.2006.05.009
   PubMed Web of Science ®Google Scholar
• Ruhe JJ, Smith N, Bradsher RW, et al. Community-onset methicillin-resistant Staphylococcus aureus skin and soft-tissue infections: impact of antimicrobial therapy on outcome. Clin Infect Diseases: an Offl Pub Infectious Dis Soc Am. 2007 Mar 15;44(6):777–784. PubMed PMID: 17304447. DOI:10.1086/511872
   PubMed Web of Science ®Google Scholar
• Eagye KJ, Kim A, Laohavaleeson S, et al. Surgical site infections: does inadequate antibiotic therapy affect patient outcomes?. Surg Infect (Larchmt). 2009 Aug;10(4):323–331. PubMed PMID: 19622027. DOI:10.1089/sur.2008.053
   PubMed Web of Science ®Google Scholar
• cited May 2. http://ecdc.europa.eu/en/publications/Publications/antimicrobial-resistance-annual-epidemiological-report.pdf
   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 Jul;34(Suppl 1):S15–9. PubMed PMID: 19560669. DOI:10.1016/S0924-8579(09)70544-8
   PubMed Web of Science ®Google Scholar
• Brink AJ. Does resistance in severe infections caused by methicillin-resistant Staphylococcus aureus give you the ‘creeps’?. Curr Opin Crit Care. 2012 Oct;18(5):451–459. PubMed PMID: 22941206. DOI:10.1097/MCC.0b013e3283578968
   PubMed Web of Science ®Google Scholar
• Nathwani D, Eckmann C, Lawson W, et al. Pan-European early switch/early discharge opportunities exist for hospitalized patients with methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections. Clin Microbiol Infect: off Pub Eur Soc Clin Microbiol Infect Dis. 2014 Oct;20(10):993–1000. PubMed PMID: 24673973. DOI:10.1111/1469-0691.12632
   PubMed Web of Science ®Google Scholar
• Duffy EMDJ, Remy J, Burak ES Delafloxacin chemical properties lead to increased potency against gram-positive pathogens, including quinolone-resistant pathogens (II) [abstract E-182]. Presented at 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 2010 Sep 12-15; Boston.
   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 PMID: 22875850. DOI:10.1093/jac/dks307
   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 PMID: 25604710. DOI:10.1517/13543784.2015.1005205
   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 01;38(1):53–65. PubMed PMID: 26718605. DOI:10.1016/j.clinthera.2015.11.019
   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 PMID: 25986539. DOI:10.3109/00498254.2015.1042946
   PubMed Web of Science ®Google Scholar
• Aminimanizani A, Beringer P, Jelliffe R. Comparative pharmacokinetics and pharmacodynamics of the newer fluoroquinolone antibacterials. PubMed PMID: 11327197 Clin Pharmacokinet. 2001;403:169–187. DOI:10.2165/00003088-200140030-00003
   PubMed Web of Science ®Google Scholar
• Stass H, Kubitza D. Pharmacokinetics and elimination of moxifloxacin after oral and intravenous administration in man. J Antimicrob Chemother. 1999 May;43(Suppl B):83–90. PubMed PMID: 10382880.
   PubMed Web of Science ®Google Scholar
• cited 2017 Sep 1; Available from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf
   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 01;38(1):39–52. PubMed PMID: 26581327. DOI:10.1016/j.clinthera.2015.10.016
   PubMed Web of Science ®Google Scholar
• Van Bambeke F. Delafloxacin, a non-zwitterionic fluoroquinolone in phase III of clinical development: evaluation of its pharmacology, pharmacokinetics, pharmacodynamics and clinical efficacy. PubMed PMID: 26119479 Future Microbiol. 2015;107:1111–1123. DOI:10.2217/fmb.15.39
   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 PMID: 27570245; PubMed Central PMCID: PMC5324641. DOI:10.1002/jcph.817
   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 May 09 PubMed PMID: 28495029. DOI:10.1016/j.clinthera.2017.04.009.
   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 PMID: 27216072; PubMed Central PMCID: PMC4958193. DOI:10.1128/AAC.00647-16
   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 PMID: 27742208. DOI:10.1016/j.ijantimicag.2016.08.012
   PubMed Web of Science ®Google Scholar
• Presented at 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); Boston. 2010 Sep 12-15; http://melinta.com/wp-content/uploads/2015/08//Rib-X_Delafloxacin_ICAAC-2010_A1-681.pdf
   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: IJID: off Pub Int Soc Infect Dis. 2015 Jan;30:67–73. PubMed PMID: 25448332. DOI:10.1016/j.ijid.2014.10.009
   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 PMID: 26679243; PubMed Central PMCID: PMC4743703. DOI:10.1093/jac/dkv411
   PubMed Web of Science ®Google Scholar
• cited 2017 Sep 1. Available from: https://clinicaltrials.gov/ct2/show/NCT01811732
   Google Scholar
• cited 2017 Sep 1. Available from: https://clinicaltrials.gov/ct2/show/NCT01984684
   Google Scholar
• Presented at IDWeek 2016. New Orleans, LA, USA. cited 2016 Oct 26-30. Available from: http://melinta.com/wp-content/uploads/2016/10/IDWEEK-1347-Baxdela-vs-VAN-AZ-302-Ph3-Results.pdf
   Google Scholar
• Presented at IDWeek 2015; San Diego, CA, USA. cited 2015 Oct 7-11; http://melinta.com/wp-content/uploads/2016/03/IDWeek2015-complete_302_ABSSSI_study_results.pdf
   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 PMID: 14506039; PubMed Central PMCID: PMC201153.
   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 supratherapeutic doses of delafloxacin on cardiac repolarization. Antimicrob Agents Chemother. 2015;59(6):3469–3473. PubMed PMID: 25845864; PubMed Central PMCID: PMC4432193. DOI:10.1128/AAC.04813-14
   PubMed Web of Science ®Google Scholar
• Presented at 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 2010 Sep 17–21; San Diego, CA, USA. http://melinta.com/wp-content/uploads/2016/03/ICAAC15-Dela_phototoxicity_ph1.pdf
   Google Scholar
• Hoover RLL, 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). CO, USA, 2013 Sep 10–13 (Abstract A-017E).
   Google Scholar
• Malincarne L, Ghebregzabher M, Moretti MV, et al. Penetration of moxifloxacin into bone in patients undergoing total knee arthroplasty. J Antimicrob Chemother. 2006 May;57(5):950–954. PubMed PMID: 16551691. DOI:10.1093/jac/dkl091
   PubMed Web of Science ®Google Scholar
• Metallidis S, Topsis D, Nikolaidis J, et al. Penetration of moxifloxacin and levofloxacin into cancellous and cortical bone in patients undergoing total hip arthroplasty. J Chemotherapy. 2007 Dec;19(6):682–687. PubMed PMID: 18230551. DOI:10.1179/joc.2007.19.6.682
   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 Mar;53(3):533–535. PubMed PMID: 14963066. DOI:10.1093/jac/dkh110
   PubMed Web of Science ®Google Scholar
• Bauer J, Siala W, Tulkens PM, et al. A combined pharmacodynamic quantitative and qualitative model reveals the potent activity of daptomycin and delafloxacin against Staphylococcus aureus biofilms. Antimicrob Agents Chemother. 2013 Jun;57(6):2726–2737. PubMed PMID: 23571532; PubMed Central PMCID: PMC3716136. DOI:10.1128/AAC.00181-13
   PubMed Web of Science ®Google Scholar
• Bassetti M, Carnelutti A, Righi E. The role of methicillin-resistant Staphylococcus aureus in skin and soft tissue infections. Curr Opin Infect Dis. 2017 Apr;30(2):150–157. PubMed PMID: 28079631. DOI:10.1097/QCO.0000000000000353
   PubMed Web of Science ®Google Scholar