An evaluation of tedizolid for the treatment of MRSA infections

References

• Pulido-Cejudo A, Guzman-Gutierrez M, Jalife-Montano A, et al. Management of acute bacterial skin and skin structure infections with a focus on patients at high risk of treatment failure. Ther Adv Infect Dis. 2017;4(5):143–161.
   PubMed Web of Science ®Google Scholar
• Doshi P. Speeding new antibiotics to market: a fake fix? BMJ. 2015;350:h1453.
   PubMedGoogle Scholar
• Tong SY, Davis JS, Eichenberger E, et al. Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management. Clin Microbiol Rev. 2015;28(3):603–661.
   PubMed Web of Science ®Google Scholar
• Payne KD, Das A, Ndiulor M, et al. Dosing strategies to optimize currently available anti-MRSA treatment options (Part 2: PO options). Expert Rev Clin Pharmacol. 2018;11(2):139–149.
   PubMed Web of Science ®Google Scholar
• Hall RG, Thatcher M, Wei W, et al. Dosing strategies to optimize currently available anti-MRSA treatment options (Part 1: IV options). Expert Rev Clin Pharmacol. 2017;10(5):493–508.
   PubMed Web of Science ®Google Scholar
• Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18–55.
   PubMed Web of Science ®Google Scholar
• Burdette SD, Trotman R. Tedizolid: the first once-daily oxazolidinone class antibiotic. Clin Infect Dis. 2015;61(8):1315–1321.
   PubMed Web of Science ®Google Scholar
• Prokocimer P, De Anda C, Fang E, et al. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA. 2013;309(6):559–569.
   PubMed Web of Science ®Google Scholar
• Moran GJ, Fang E, Corey GR, et al. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2014;14(8):696–705.
   PubMed Web of Science ®Google Scholar
• Rybak JM, Marx K, Martin CA. Early experience with tedizolid: clinical efficacy, pharmacodynamics, and resistance. Pharmacother. 2014;34(11):1198–1208.
   PubMed Web of Science ®Google Scholar
• Merck. Sivextro (tedizolid phosphate) prescribing information. 2017 Aug cited 2018 Apr 18. Available from: https://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro_pi.pdf
   Google Scholar
• Prokocimer P, Bien P, Deanda C, et al. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012;56(9):4608–4613.
   PubMed Web of Science ®Google Scholar
• Sahm DF, Deane J, Bien PA, et al. Results of the surveillance of tedizolid activity and resistance program: in vitro susceptibility of gram-positive pathogens collected in 2011 and 2012 from the United States and Europe. Diagn Microbiol Infect Dis. 2015;81(2):112–118.
   PubMed Web of Science ®Google Scholar
• Schaadt R, Sweeney D, Shinabarger D, et al. In vitro activity of TR-700, the active ingredient of the antibacterial prodrug TR-701, a novel oxazolidinone antibacterial agent. Antimicrob Agents Chemother. 2009;53(8):3236–3239.
   PubMed Web of Science ®Google Scholar
• Rodriguez-Avial I, Culebras E, Betriu C, et al. In vitro activity of tedizolid (TR-700) against linezolid-resistant staphylococci. J Antimicrob Chemother. 2012;67(1):167–169.
   PubMed Web of Science ®Google Scholar
• Shaw KJ, Poppe S, Schaadt R, et al. In vitro activity of TR-700, the antibacterial moiety of the prodrug TR-701, against linezolid-resistant strains. Antimicrob Agents Chemother. 2008;52(12):4442–4447.
   PubMed Web of Science ®Google Scholar
• Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibilty testing. In: CLSI supplement M100. 28th ed. Wayne (PA): CLSI; 2018.
   Google Scholar
• The European Committee on Antimicrobial Susceptibility Testing (EUCAST). Breakpoint tables for interpretation of MICs and zone diameters, version 8.0. 2018 cited 2018 Apr 18. Available from: http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint_tables/v_8.0_Breakpoint_Tables.xlsx
   Google Scholar
• Le VT, Le HN, Pinheiro MG, et al. Effects of tedizolid phosphate on survival outcomes and suppression of production of staphylococcal toxins in a rabbit model of methicillin-resistant Staphylococcus aureus necrotizing pneumonia. Antimicrob Agents Chemother. 2017;61(4):e02734–16.
   PubMed Web of Science ®Google Scholar
• Kaku N, Morinaga Y, Takeda K, et al. Antimicrobial and immunomodulatory effects of tedizolid against methicillin-resistant Staphylococcus aureus in a murine model of hematogenous pulmonary infection. Int J Med Microbiol. 2016;306(6):421–428.
   PubMed Web of Science ®Google Scholar
• Flanagan S, Passarell J, Lu Q, et al. Tedizolid population pharmacokinetics, exposure response, and target attainment. Antimicrob Agents Chemother. 2014;58(11):6462–6470.
   PubMed Web of Science ®Google Scholar
• Flanagan SD, Bien PA, Munoz KA, et al. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacother. 2014;34(3):240–250.
   PubMed Web of Science ®Google Scholar
• Flanagan S, Minassian SL, Morris D, et al. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014;58(11):6471–6476.
   PubMed Web of Science ®Google Scholar
• Flanagan S, Minassian SL, Passarell JA, et al. Pharmacokinetics of tedizolid in obese and nonobese subjects. J Clin Pharmacol. 2017;57(10):1290–1294.
   PubMed Web of Science ®Google Scholar
• Pai MP. Pharmacokinetics of tedizolid in morbidly obese and covariate-matched nonobese adults. Antimicrob Agents Chemother. 2016;60(8):4585–4589.
   PubMed Web of Science ®Google Scholar
• Flanagan SD, Minassian SL, Prokocimer P. Pharmacokinetics, safety, and tolerability of tedizolid phosphate in elderly subjects. Clin Pharmacol Drug Dev. 2018 [cited Aug 16];[7]. DOI:10.1002/cpdd.426.
   Web of Science ®Google Scholar
• Louie A, Liu W, Kulawy R, et al. In vivo pharmacodynamics of torezolid phosphate (TR-701), a new oxazolidinone antibiotic, against methicillin-susceptible and methicillin-resistant Staphylococcus aureus strains in a mouse thigh infection model. Antimicrob Agents Chemother. 2011;55(7):3453–3460.
   PubMed Web of Science ®Google Scholar
• Drusano GL, Liu W, Kulawy R, et al. Impact of granulocytes on the antimicrobial effect of tedizolid in a mouse thigh infection model. Antimicrob Agents Chemother. 2011;55(11):5300–5305.
   PubMed Web of Science ®Google Scholar
• Mikamo H, Takesue Y, Iwamoto Y, et al. Efficacy, safety and pharmacokinetics of tedizolid versus linezolid in patients with skin and soft tissue infections in Japan - Results of a randomised, multicentre phase 3 study. J Infect Chemother. 2018;24(6):434–442.
   PubMed Web of Science ®Google Scholar
• Lodise TP, Fang E, Minassian SL, et al. Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials. Antimicrob Agents Chemother. 2014;58(12):7198–7204.
   PubMed Web of Science ®Google Scholar
• Gerson SL, Kaplan SL, Bruss JB, et al. Hematologic effects of linezolid: summary of clinical experience. Antimicrob Agents Chemother. 2002;46(8):2723–2726.
   PubMed Web of Science ®Google Scholar
• Lodise TP, Bidell MR, Flanagan SD, et al. Characterization of the haematological profile of 21 days of tedizolid in healthy subjects. J Antimicrob Chemother. 2016;71(9):2553–2558.
   PubMed Web of Science ®Google Scholar
• Flanagan S, Bartizal K, Minassian SL, et al. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013;57(7):3060–3066.
   PubMed Web of Science ®Google Scholar
• Douros A, Grabowski K, Stahlmann R. Drug-drug interactions and safety of linezolid, tedizolid, and other oxazolidinones. Expert Opin Drug Metab Toxicol. 2015;11(12):1849–1859.
   PubMed Web of Science ®Google Scholar
• Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of tedizolid and pseudoephedrine administered alone or in combination in healthy volunteers. J Clin Med. 2018;7(6):E150.
   PubMed Web of Science ®Google Scholar
• Das D, Tulkens PM, Mehra P, et al. Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: safety summary. Clin Infect Dis. 2014;58(Suppl 1):S51–7.
   PubMed Web of Science ®Google Scholar
• Flanagan S, McKee EE, Das D, et al. Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function. Antimicrob Agents Chemother. 2015;59(1):178–185.
   PubMed Web of Science ®Google Scholar
• Milosevic TV, Payen VL, Sonveaux P, et al. Mitochondrial alterations (inhibition of mitochondrial protein expression, oxidative metabolism, and ultrastructure) induced by linezolid and tedizolid at clinically relevant concentrations in cultured human HL-60 promyelocytes and THP-1 monocytes. Antimicrob Agents Chemother. 2018;62(3):e01599–17.
   PubMed Web of Science ®Google Scholar
• Fang E, Munoz KA, Prokocimer P. Characterization of neurologic and ophthalmologic safety of oral administration of tedizolid for up to 21 days in healthy volunteers. Am J Ther. 2017;24(2):e227–e33.
   PubMed Web of Science ®Google Scholar
• Nigo M, Luce AM, Arias CA. Long term use of tedizolid as suppressive therapy for recurrent methicillin-resistant Staphylococcus aureus graft infection. Clin Infect Dis. 2018;66(12):1975–1976.
   PubMed Web of Science ®Google Scholar
• Kim T, Wills A, Markus A, et al. Safety and tolerability of long term use of tedizolid for treatment of nontuberculous mycobacterial infections. Open Forum Infect Dis. 2016;3(Suppl 1):577.
   Google Scholar
• Martínez Álvarez RM, Pardo IN, García EM, et al. Long-term safety of tedizolid in a patient with spondilodiscitis after switch from linezolid due to toxicity. Infect Dis Clin Pract. 2018. [cited 2018 Apr 18];[3]. DOI:10.1097/IPC.0000000000000623
   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;7(2):197–217.
   PubMed Web of Science ®Google Scholar
• Goldman JL, Jackson MA, Herigon JC, et al. Trends in adverse reactions to trimethoprim-sulfamethoxazole. Pediatrics. 2013;131(1):e103–8.
   PubMed Web of Science ®Google Scholar
• Moore DE. Drug-induced cutaneous photosensitivity: incidence, mechanism, prevention and management. Drug Saf. 2002;25(5):345–372.
   PubMed Web of Science ®Google Scholar
• Sanchez AR, Rogers RS 3rd, Sheridan PJ. Tetracycline and other tetracycline-derivative staining of the teeth and oral cavity. Int J Dermatol. 2004;43(10):709–715.
   PubMed Web of Science ®Google Scholar
• Fernandes P, Martens E. Antibiotics in late clinical development. Biochem Pharmacol. 2017;133:152–163.
   PubMed Web of Science ®Google Scholar
• Housman ST, Pope JS, Russomanno J, et al. Pulmonary disposition of tedizolid following administration of once-daily oral 200-milligram tedizolid phosphate in healthy adult volunteers. Antimicrob Agents Chemother. 2012;56(5):2627–2634.
   PubMed Web of Science ®Google Scholar
• Stainton SM, Monogue ML, Baummer-Carr A, et al. Comparative assessment of tedizolid pharmacokinetics and tissue penetration between diabetic patients with wound infections and healthy volunteers via in vivo microdialysis. Antimicrob Agents Chemother. 2018;62(1):e01880–17.
   PubMed Web of Science ®Google Scholar
• Chan LC, Basuino L, Dip EC, et al. Comparative efficacies of tedizolid phosphate, vancomycin, and daptomycin in a rabbit model of methicillin-resistant Staphylococcus aureus endocarditis. Antimicrob Agents Chemother. 2015;59(6):3252–3256.
   PubMed Web of Science ®Google Scholar
• Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis in adults: diagnosis, antimicrobial therapy, and management of complications: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2015;132(15):1435–1486.
   PubMed Web of Science ®Google Scholar
• Shorr AF, Kunkel MJ, Kollef M. Linezolid versus vancomycin for Staphylococcus aureus bacteraemia: pooled analysis of randomized studies. J Antimicrob Chemother. 2005;56(5):923–929.
   PubMed Web of Science ®Google Scholar
• Falagas ME, Siempos II, Vardakas KZ. Linezolid versus glycopeptide or beta-lactam for treatment of Gram-positive bacterial infections: meta-analysis of randomised controlled trials. Lancet Infect Dis. 2008;8(1):53–66.
   PubMed Web of Science ®Google Scholar
• Myrianthefs P, Markantonis SL, Vlachos K, et al. Serum and cerebrospinal fluid concentrations of linezolid in neurosurgical patients. Antimicrob Agents Chemother. 2006;50(12):3971–3976.
   PubMed Web of Science ®Google Scholar
• Tsona A, Metallidis S, Foroglou N, et al. Linezolid penetration into cerebrospinal fluid and brain tissue. J Chemother. 2010;22(1):17–19.
   PubMed Web of Science ®Google Scholar
• Luque S, Grau S, Alvarez-Lerma F, et al. Plasma and cerebrospinal fluid concentrations of linezolid in neurosurgical critically ill patients with proven or suspected central nervous system infections. Int J Antimicrob Agents. 2014;44(5):409–415.
   PubMed Web of Science ®Google Scholar
• Sipahi OR, Bardak S, Turhan T, et al. Linezolid in the treatment of methicillin-resistant staphylococcal post-neurosurgical meningitis: a series of 17 cases. Scand J Infect Dis. 2011;43(10):757–764.
   PubMed Web of Science ®Google Scholar
• Sipahi OR, Bardak-Ozcem S, Turhan T, et al. Vancomycin versus linezolid in the treatment of methicillin-resistant Staphylococcus aureus meningitis. Surg Infect (Larchmt). 2013;14(4):357–362.
   PubMed Web of Science ®Google Scholar