154
Views
16
CrossRef citations to date
0
Altmetric
Review

Tedizolid phosphate for the treatment of acute bacterial skin and skin-structure infections: an evidence-based review of its place in therapy

, , , &
Pages 31-40 | Published online: 05 Jul 2019

References

  • Esposito S, Noviello S, Leone S. Epidemiology and microbiology of skin and soft tissue infections. Curr Opin Infect Dis. 2016;29(2):109–115. doi:10.1097/QCO.0000000000000239
  • Garau J, Ostermann H, Medina J, et al. Current management of patients hospitalized with complicated skin and soft tissue infections across Europe (2010–2011): assessment of clinical practice patterns and real-life effectiveness of antibiotics from the REACH study. Clin Microbiol Infect. 2013;19(9):E377–E385. doi:10.1111/1469-0691.12235
  • Edelsberg J, Taneja C, Zervos M, et al. Trends in US hospital admissions for skin and soft tissue infections. Emerg Infect Dis. 2009;15(9):1516–1518. doi:10.3201/eid1509.081228
  • 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. doi:10.1016/j.annemergmed.2007.12.004
  • Chua K, Laurent F, Coombs G, Grayson ML, Howden BP. Antimicrobial resistance: not community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA)! A clinician’s guide to community MRSA - its evolving antimicrobial resistance and implications for therapy. Clin Infect Dis. 2011;52(1):99–114. doi:10.1093/cid/ciq067
  • Saeed K, Gould I, Esposito S, et al. Panton-valentine leukocidin-positive staphylococcus aureus: a position statement from the International Society of Chemotherapy. Int J Antimicrob Agents. 2018;51(1):16–25. doi:10.1016/j.ijantimicag.2017.11.002
  • 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. doi:10.1016/S0924-8579(09)70544-8
  • Moran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. 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. doi:10.1016/S1473-3099(14)70737-6
  • Prokocimer P, De Anda C, Fang E, Mehra P, Das A. 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. doi:10.1001/jama.2013.241
  • Burdette SD, Trotman R. Tedizolid: the first once-daily oxazolidinone class antibiotic. Clin Infect Dis. 2015;61(8):1315–1321. doi:10.1093/cid/civ501
  • Ferrandez O, Urbina O, Grau S. Critical role of tedizolid in the treatment of acute bacterial skin and skin structure infections. Drug Des Devel Ther. 2017;11:65–82. doi:10.2147/DDDT.S84667
  • Locke JB, Finn J, Hilgers M, et al. Structure-activity relationships of diverse oxazolidinones for linezolid-resistant Staphylococcus aureus strains possessing the cfr methyltransferase gene or ribosomal mutations. Antimicrob Agents Chemother. 2010;54(12):5337–5343. doi:10.1128/AAC.00663-10
  • Kisgen JJ, Mansour H, Unger NR, Childs LM. Tedizolid: a new oxazolidinone antimicrobial. Am J Health Syst Pharm. 2014;71(8):621–633. doi:10.2146/ajhp130482
  • Zhanel GG, Love R, Adam H, et al. Tedizolid: a novel oxazolidinone with potent activity against multidrug-resistant gram-positive pathogens. Drugs. 2015;75(3):253–270. doi:10.1007/s40265-015-0352-7
  • Karlowsky JA, Hackel MA, Bouchillon SK, Alder J, Sahm DF. In vitro activities of tedizolid and comparator antimicrobial agents against clinical isolates of Staphylococcus aureus collected in 12 countries from 2014 to 2016. Diagn Microbiol Infect Dis. 2017;89(2):151–157. doi:10.1016/j.diagmicrobio.2017.07.001
  • Lee Y, Hong SK, Choi S, Im W, Yong D, Lee K. In vitro activity of tedizolid against gram-positive bacteria in patients with skin and skin structure infections and hospital-acquired pneumonia: a Korean multicenter study. Ann Lab Med. 2015;35(5):523–530. doi:10.3343/alm.2015.35.5.523
  • Vanegas Munera JM, Ocampo Rios AM, Urrego DM, Jimenez Quiceno JN. In vitro susceptibility of methicillin-resistant Staphylococcus aureus isolates from skin and soft tissue infections to vancomycin, daptomycin, linezolid and tedizolid. Braz J Infect Dis. 2017;21(5):493–499. doi:10.1016/j.bjid.2017.03.010
  • Bai B, Hu K, Li H, et al. Effect of tedizolid on clinical Enterococcus isolates: in vitro activity, distribution of virulence factor, resistance genes and multilocus sequence typing. FEMS Microbiol Lett. 2018;365:3. doi:10.1093/femsle/fnx284
  • Barber KE, Smith JR, Raut A, Rybak MJ. Evaluation of tedizolid against Staphylococcus aureus and enterococci with reduced susceptibility to vancomycin, daptomycin or linezolid. J Antimicrob Chemother. 2016;71(1):152–155. doi:10.1093/jac/dkv302
  • Bensaci M, Sahm D. Surveillance of tedizolid activity and resistance: in vitro susceptibility of gram-positive pathogens collected over 5 years from the United States and Europe. Diagn Microbiol Infect Dis. 2017;87(2):133–138. doi:10.1016/j.diagmicrobio.2016.10.009
  • Long KS, Poehlsgaard J, Kehrenberg C, Schwarz S, Vester B. The Cfr rRNA methyltransferase confers resistance to phenicols, lincosamides, oxazolidinones, pleuromutilins, and streptogramin A antibiotics. Antimicrob Agents Chemother. 2006;50(7):2500–2505. doi:10.1128/AAC.00131-06
  • Rybak JM, Roberts K. Tedizolid phosphate: a next-generation oxazolidinone. Infect Dis Ther. 2015. doi:10.1007/s40121-015-0060-3
  • Wilcox MH, Dmitrieva N, Gales AC, et al. Susceptibility testing and reporting of new antibiotics with a focus on tedizolid: an international working group report. Future Microbiol. 2017;12:1523–1532. doi:10.2217/fmb-2017-0106
  • Wang Y, Lv Y, Cai J, et al. A novel gene, optrA, that confers transferable resistance to oxazolidinones and phenicols and its presence in Enterococcus faecalis and Enterococcus faecium of human and animal origin. J Antimicrob Chemother. 2015;70(8):2182–2190. doi:10.1093/jac/dkv116
  • Binyamin D, Nitzan O, Azrad M, Hamo Z, Koren O, Peretz A. In vitro activity of tedizolid, dalbavancin, and ceftobiprole against clostridium difficile. Front Microbiol. 2018;9:1256. doi:10.3389/fmicb.2018.01256
  • Goldstein EJ, Citron DM, Tyrrell KL, Leoncio ES, Merriam CV. The underappreciated in vitro activity of tedizolid against Bacteroides fragilis species, including strains resistant to metronidazole and carbapenems. Anaerobe. 2017;43:1–3. doi:10.1016/j.anaerobe.2016.09.008
  • Brown-Elliott BA, Wallace RJ Jr. In vitro susceptibility testing of tedizolid against isolates of Nocardia. Antimicrob Agents Chemother. 2017;61:12. doi:10.1128/AAC.01537-17
  • Deshpande D, Srivastava S, Pasipanodya JG, Lee PS, Gumbo T. Tedizolid is highly bactericidal in the treatment of pulmonary Mycobacterium avium complex disease. J Antimicrob Chemother. 2017;72(suppl_2):i30–i35. doi:10.1093/jac/dkx305
  • Heimbach T, Oh DM, Li LY, et al. Absorption rate limit considerations for oral phosphate prodrugs. Pharm Res. 2003;20(6):848–856.
  • Flanagan S, Fang E, Munoz KA, Minassian SL, Prokocimer PG. Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Pharmacotherapy. 2014;34(9):891–900. doi:10.1002/phar.1458
  • Hall RG 2nd, Michaels HN. Profile of tedizolid phosphate and its potential in the treatment of acute bacterial skin and skin structure infections. Infect Drug Resist. 2015;8:75–82. doi:10.2147/IDR.S56691
  • Stalker DJ, Jungbluth GL. Clinical pharmacokinetics of linezolid, a novel oxazolidinone antibacterial. Clin Pharmacokinet. 2003;42(13):1129–1140. doi:10.2165/00003088-200342130-00004
  • Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014;34(3):240–250. doi:10.1002/phar.1337
  • McBride D, Krekel T, Hsueh K, Durkin MJ. Pharmacokinetic drug evaluation of tedizolid for the treatment of skin infections. Expert Opin Drug Metab Toxicol. 2017;13(3):331–337. doi:10.1080/17425255.2017.1290080
  • Ong V, Flanagan S, Fang E, et al. Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Drug Metab Dispos. 2014;42(8):1275–1284. doi:10.1124/dmd.113.056697
  • Bradley JS, Flanagan SD, Arrieta AC, Jacobs R, Capparelli E, Prokocimer P. Pharmacokinetics, safety and tolerability of single oral or intravenous administration of 200 mg tedizolid phosphate in adolescents. Pediatr Infect Dis J. 2016;35(6):628–633. doi:10.1097/INF.0000000000001096
  • Pai MP. Pharmacokinetics of tedizolid in morbidly obese and covariate-matched nonobese adults. Antimicrob Agents Chemother. 2016;60(8):4585–4589. doi:10.1128/AAC.00682-16
  • Lodise TP, Drusano GL. Use of pharmacokinetic/pharmacodynamic systems analyses to inform dose selection of tedizolid phosphate. Clin Infect Dis. 2014;58(Suppl 1):S28–S34. doi:10.1093/cid/cit615
  • Prokocimer P, Bien P, Surber J, et al. Phase 2, randomized, double-blind, dose-ranging study evaluating the safety, tolerability, population pharmacokinetics, and efficacy of oral torezolid phosphate in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2011;55(2):583–592. doi:10.1128/AAC.00076-10
  • Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. 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. doi:10.1128/AAC.00458-12
  • Moran GJ, De Anda C, Das AF, Green S, Mehra P, Efficacy PP. Safety of tedizolid and linezolid for the treatment of acute bacterial skin and skin structure infections in injection drug users: analysis of two clinical trials. Infect Dis Ther. 2018;7(4):509–522. doi:10.1007/s40121-018-0211-4
  • De Anda C, Anuskiewicz S, Prokocimer P, Vazquez J. Outpatient treatment of acute bacterial skin and skin structure infections (ABSSSI) with tedizolid phosphate and linezolid in patients in the United States: subgroup analysis of 2 randomized phase 3 trials. Medicine (Baltimore). 2017;96(52):e9163. doi:10.1097/MD.0000000000009163
  • Ortiz-Covarrubias A, Fang E, Prokocimer PG, et al. Efficacy, safety, tolerability and population pharmacokinetics of tedizolid, a novel antibiotic, in Latino patients with acute bacterial skin and skin structure infections. Braz J Infect Dis. 2016;20(2):184–192. doi:10.1016/j.bjid.2015.12.007
  • Joseph WS, Culshaw D, Anuskiewicz S, De Anda C, Prokocimer P. Tedizolid and linezolid for treatment of acute bacterial skin and skin structure infections of the lower extremity versus non-lower-extremity infectionspooled analysis of two phase 3 trials. J Am Podiatr Med Assoc. 2017;107(4):264–271. doi:10.7547/15-218
  • Sandison T, De Anda C, Fang E, Das AF, Prokocimer P. Clinical response of tedizolid versus linezolid in acute bacterial skin and skin structure infections by severity measure using a pooled analysis from two phase 3 double-blind trials. Antimicrob Agents Chemother. 2017;61:5. doi:10.1128/AAC.02687-16
  • 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. doi:10.1016/j.jiac.2018.01.010
  • Lodise TP, Fang E, Minassian SL, Prokocimer PG. 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. doi:10.1128/AAC.03509-14
  • Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. 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. doi:10.1128/AAC.00431-13
  • Hall RG 2nd, Smith WJ, Putnam WC, Pass SE. An evaluation of tedizolid for the treatment of MRSA infections. Expert Opin Pharmacother. 2018;19(13):1489–1494. doi:10.1080/146565662018.1519021
  • Das D, Tulkens PM, Mehra P, Fang E, Prokocimer P. Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: safety summary. Clin Infect Dis. 2014;58(Suppl 1):S51–S57. doi:10.1093/cid/cit618
  • 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. doi:10.3390/jcm7060150
  • European Medicines Agency. SIVEXTRO®. Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002846/WC500184803.pdf. Accessed May 22, 2019.
  • 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–e233. doi:10.1097/MJT.0000000000000534
  • Bassetti M, Baguneid M, Bouza E, Dryden M, Nathwani D, Wilcox M. European perspective and update on the management of complicated skin and soft tissue infections due to methicillin-resistant Staphylococcus aureus after more than 10 years of experience with linezolid. Clin Microbiol Infect. 2014;20(Suppl 4):3–18. doi:10.1111/1469-0691.12463
  • Bassetti M, Eckmann C, Peghin M, Carnelutti A, Righi E. When to switch to an oral treatment and/or to discharge a patient with skin and soft tissue infections. Curr Opin Infect Dis. 2018;31(2):163–169. doi:10.1097/QCO.0000000000000434
  • Wong CH, Khin LW, Heng KS, Tan KC, Low CO. The LRINEC (Laboratory risk indicator for necrotizing fasciitis) score: a tool for distinguishing necrotizing fasciitis from other soft tissue infections. Crit Care Med. 2004;32(7):1535–1541.
  • Belkova YA, Rachina SA, Kozlov RS, Golub AV, Portnyagina US, Shamaeva SH. Cost implications of tedizolid introduction for the treatment of complicated skin and soft tissue infections in a Russian multi-field hospital. Value Health. 2017;20(9):A782. doi:10.1016/j.jval.2017.08.2277
  • Bouza E, Munoz P, Burillo A. The role of tedizolid in skin and soft tissue infections. Curr Opin Infect Dis. 2018;31(2):131–140. doi:10.1097/QCO.0000000000000439
  • Abad L, Tafani V, Tasse J, et al. Evaluation of the ability of linezolid and tedizolid to eradicate intraosteoblastic and biofilm-embedded Staphylococcus aureus in the bone and joint infection setting. J Antimicrob Chemother. 2019;74:625–632.
  • Bayer AS, Abdelhady W, Li L, Gonzales R, Xiong YQ. Comparative efficacies of tedizolid phosphate, linezolid, and vancomycin in a murine model of subcutaneous catheter-related biofilm infection due to methicillin-susceptible and -resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2016;60(8):5092–5096. doi:10.1128/AAC.00880-16
  • 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. doi:10.1016/j.ijmm.2016.05.010
  • Kidd JM, Abdelraouf K, Nicolau DP. Comparative efficacy of human-simulated epithelial lining fluid exposures of tedizolid, linezolid and vancomycin in neutropenic and immunocompetent murine models of staphylococcal pneumonia. J Antimicrob Chemother. 2019;74:970–977.
  • 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. doi:10.1128/AAC.02734-16
  • Matin A, Sharma S, Mathur P, Apewokin SK. Myelosuppression-sparing treatment of central nervous system nocardiosis in a multiple myeloma patient utilizing a tedizolid-based regimen: a case report. Int J Antimicrob Agents. 2017;49(4):488–492. doi:10.1016/j.ijantimicag.2016.11.032
  • Park KH, Greenwood-Quaintance KE, Mandrekar J, Patel R. Activity of tedizolid in methicillin-resistant Staphylococcus aureus experimental foreign body-associated osteomyelitis. Antimicrob Agents Chemother. 2016;60(11):6568–6572. doi:10.1128/AAC.01248-16
  • Si S, Durkin MJ, Mercier MM, Yarbrough ML, Liang SY. Successful treatment of prosthetic joint infection due to vancomycin-resistant enterococci with tedizolid. Infect Dis Clin Pract (Baltim Md). 2017;25(2):105–107. doi:10.1097/IPC.0000000000000469
  • 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.
  • Kim T, Wills A, Markus A, Prevots DR, Olivier KN. Safety and tolerability of long term use of tedizolid for treatment of nontuberculous mycobacterial infections. Open Forum Infect Dis. 2016;3(suppl_1):577. doi:10.1093/ofid/ofw172.440
  • Nukui Y, Hatakeyama S, Okamoto K, et al. High plasma linezolid concentration and impaired renal function affect development of linezolid-induced thrombocytopenia. J Antimicrob Chemother. 2013;68(9):2128–2133. doi:10.1093/jac/dkt133
  • McCool R, Gould IM, Eales J, et al. Systematic review and network meta-analysis of tedizolid for the treatment of acute bacterial skin and skin structure infections caused by MRSA. BMC Infect Dis. 2017;17(1):39. doi:10.1186/s12879-017-2757-2
  • Cipriani A, Higgins JP, Geddes JR, Salanti G. Conceptual and technical challenges in network meta-analysis. Ann Intern Med. 2013;159(2):130–137. doi:10.7326/0003-4819-159-2-201307160-00008