Profile of tedizolid phosphate and its potential in the treatment of acute bacterial skin and skin structure infections

Infection and Drug Resistance

Volumn 8, Issue , 2015, Pages 75-82

  Hall, Ronald G ^a   Michaels, Heidi N ^a  

^a TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER   (United States)

Author keywords

ABSSSI; Monoamine oxidase; MRSA; Oxazolidinone; Tedizolid; VRE

Indexed keywords

ALANINE AMINOTRANSFERASE; LINEZOLID; TEDIZOLID;

ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTION; ALPHA HEMOLYTIC STREPTOCOCCUS; ANTIBIOTIC RESISTANCE; AREA UNDER THE CURVE; BACTERIAL SKIN DISEASE; BACTERICIDAL ACTIVITY; BETA HEMOLYTIC STREPTOCOCCUS; COAGULASE NEGATIVE STAPHYLOCOCCUS; COMPLICATED SKIN AND SKIN STRUCTURE INFECTION; COST EFFECTIVENESS ANALYSIS; DIALYSIS; DIARRHEA; DRUG BIOAVAILABILITY; DRUG COST; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; DRUG TISSUE LEVEL; DYSPEPSIA; END STAGE RENAL DISEASE; ENTEROCOCCUS; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL DISEASE; GLOMERULUS FILTRATION RATE; HAEMOPHILUS INFLUENZAE; HEART INFARCTION; HUMAN; IN VITRO STUDY; INFECTION; INFESTATION; LEGIONELLA PNEUMOPHILA; LISTERIA MONOCYTOGENES; LIVER DYSFUNCTION; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MITOCHONDRIAL TOXICITY; MORAXELLA CATARRHALIS; MULTICENTER STUDY (TOPIC); NAUSEA; NEUROLOGIC DISEASE; NEUROPATHY; NOCARDIA BRASILIENSIS; NONHUMAN; OBESITY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SEROTONIN SYNDROME; SIDE EFFECT; SKIN INFECTION; STAPHYLOCOCCUS AUREUS; STRUCTURE ACTIVITY RELATION; TERATOGENICITY; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; VOMITING;

EID: 84929416878     PISSN: 11786973     EISSN: 11786973     Source Type: Journal    
DOI: 10.2147/IDR.S56691     Document Type: Review

References (37)

1. 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.
2. Jarvis WR, Jarvis AA, Chinn RY. National prevalence of methicillin-resistant Staphylococcus aureus in inpatients at United States health care facilities, 2010. Am J Infect Control. 2012;40(3):194-200.
3. Centers for Disease Control and Prevention. Active Bacterial Core Surveillance Report, Emerging Infections Program Network, Methicillin-Resistant Staphylococcus aureus. 2012.
4. Ray GT, Suaya JA, Baxter R. Incidence, microbiology, and patient characteristics of skin and soft-tissue infections in a US population: a retrospective population-based study. BMC Infect Dis. 2013;13:252.
5. Lodise TP, Fang E, Minassian SL, Prokocimer P. 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.
6. 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.
7. Chen H, Yang Q, Zhang R, et al. In vitro antimicrobial activity of the novel oxazolidinone tedizolid and comparator agents against Staphylococcus aureus and linezolid-resistant Gram-positive pathogens: a multicentre study in China. Int J Antimicrob Agents. 2014;44(3):276-277.
8. 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.
9. Rodriguez-Avial I, Culebras E, Betriu C, Morales G, Pena I, Picazo JJ. In vitro activity of tedizolid (TR-700) against linezolid-resistant staphylococci. J Antimicrob Chemother. 2012;67(1):167-169.
10. 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.
11. Schaadt R, Sweeney D, Shinabarger D, Zurenko G. 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.
12. Thomson KS, Goering RV. Activity of tedizolid (TR-700) against well-characterized methicillin-resistant Staphylococcus aureus strains of diverse epidemiological origins. Antimicrob Agents Chemother. 2013;57(6):2892-2895.
13. Locke JB, Zurenko GE, Shaw KJ, Bartizal K. Tedizolid for the management of human infections: in vitro characteristics. Clin Infect Dis. 2014;58(Suppl 1):S35-S42.
14. 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.
15. Sahre M, Sabarinath S, Grant M, et al. Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers. Int J Antimicrob Agents. 2012;40(1):51-54.
16. Sivextro™ lyophilized powder for intravenous injection, oral tablets, tedizolid phosphate lyophilized powder for intravenous injection, oral tablets [Product information]. Cubist Pharmaceuticals, Lexington, MA. 2014.
17. 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.
18. Flanagan S, Passarell J, Lu Q, Fiedler-Kelly J, Ludwig E, Prokocimer P. Tedizolid population pharmacokinetics, exposure response, and target attainment. Antimicrob Agents Chemother. 2014;58(11):6462-6470.
19. Flanagan S, Minassian SL, Passarell J, Fiedler-Kelly J, Prokocimer P. Tedizolid plasma pharmacokinetics are comparable in obese and nonobese patients and healthy subjects. Paper presented at: 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); May 10-13, 2014; Barcelona, Spain.
20. Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults. Available from: https://www.clinicaltrials.gov/ct2/show/NCT02342418?term=tedizolid&rank=3. Accessed January 30, 2015.
21. Louie A, Liu W, Kulawy R, Drusano GL. 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.
22. Drusano GL, Liu W, Kulawy R, Louie A. Impact of granulocytes on the antimicrobial effect of tedizolid in a mouse thigh infection model. Antimicrob Agents Chemother. 2011;55(11):5300-5305.
23. Keel RA, Tessier PR, Crandon JL, Nicolau DP. Comparative efficacies of human simulated exposures of tedizolid and linezolid against Staphylococcus aureus in the murine thigh infection model. Antimicrob Agents Chemother. 2012;56(8):4403-4407.
24. 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.
25. 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.
26. 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.
27. 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.
28. 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.
29. Patel N, VanDeWall H, Tristani L, et al. A comparative evaluation of adverse platelet outcomes among Veterans' Affairs patients receiving linezolid or vancomycin. J Antimicrob Chemother. 2012;67(3): 727-735.
30. Athanasakis K, Petrakis I, Ollandezos M, et al. Antibacterial treatment of meticillin-resistant staphylococcus aureus complicated skin and soft tissue infections: a cost and budget impact analysis in Greek hospitals. Infect Dis Ther. 2014;3(2):257-268.
31. Barron J, Turner R, Jaeger M, Adamson W, Singer J. Comparing the use of intravenous antibiotics under the medical benefit with the use of oral antibiotics under the pharmacy benefit in treating skin and soft tissue infections. Manag Care. 2012;21(9):44-52.
32. Menzin J, Marton JP, Meyers JL, Carson RT, Rothermel CD, Friedman M. Inpatient treatment patterns, outcomes, and costs of skin and skin structure infections because of Staphylococcus aureus. Am J Infect Control. 2010;38(1):44-49.
33. Schurmann D, Sorensen SV, De Cock E, Duttagupta S, Resch A. Cost-effectiveness of linezolid versus vancomycin for hospitalised patients with complicated skin and soft-tissue infections in Germany. Eur J Health Econ. 2009;10(1):65-79.
34. De Cock E, Sorensen S, Levrat F, et al. Cost-effectiveness of linezolid versus vancomycin for hospitalized patients with complicated skin and soft-tissue infections in France. Med Mal Infect. 2009;39(5): 330-340.
35. McCollum M, Sorensen SV, Liu LZ. A comparison of costs and hospital length of stay associated with intravenous/oral linezolid or intravenous vancomycin treatment of complicated skin and soft-tissue infections caused by suspected or confirmed methicillin-resistant Staphylococcus aureus in elderly US patients. Clin Ther. 2007;29(3):469-477.
36. Sharpe JN, Shively EH, Polk HC Jr. Clinical and economic outcomes of oral linezolid versus intravenous vancomycin in the treatment of MRSA-complicated, lower-extremity skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. Am J Surg. 2005;189(4):425-428.
37. Rosner AJ, Becker DL, Wong AH, Miller E, Conly JM. The costs and consequences of methicillin-resistant Staphylococcus aureus infection treatments in Canada. Can J Infect Dis Med Microbiol. 2004;15(4): 213-220.