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-
1
Edelsberg J, Taneja C, Zervos M, et al: Trends in US hospital admissions for skin and soft tissue infections. Emerg Infect Dis 15: 1516, 2009.
-
2
Hersh AL, Chambers HF, Maselli JH, et al: National trends in ambulatory visits and antibiotic prescribing for skin and soft-tissue infections. Arch Intern Med 168: 1585, 2008.
-
3
Taira BR, Singer AJ, Thode HC, Jr, et al: National epidemiology of cutaneous abscesses: 1996 to 2005. Am J Emerg Med 27: 289, 2009.
-
4
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 51: 291, 2008.
-
5
US Department of Health and Human Services: Guidance for industry uncomplicated and complicated skin and skin structure infections — developing antimicrobial drugs for treatment. Available at: http://www.fda.gov/ohrms/dockets/98fr/2566dft.pdf. Accessed May 2, 2016.
-
6
US Department of Health and Human Services: Guidance for industry acute bacterial skin and skin structure infections: developing drugs for treatment. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071185.pdf. Accessed September 16, 2015.
-
7
Moran GJ, Krishnadasan A, Gorwitz RJ, et al: Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med 355: 666, 2006.
-
8
King MD, Humphrey BJ, Wang YF, et al: Emergence of community-acquired methicillin-resistant Staphylococcus aureus USA 300 clone as the predominant cause of skin and soft-tissue infections. Ann Intern Med 144: 309, 2006.
-
9
Talan DA, Krishnadasan A, Gorwitz RJ, et al: Comparison of Staphylococcus aureus from skin and soft-tissue infections in US emergency department patients, 2004 and 2008. Clin Infect Dis 53: 144, 2011.
-
10
Zervos MJ, Freeman K, Vo L, et al: Epidemiology and outcomes of complicated skin and soft tissue infections in hospitalized patients. J Clin Med 50: 238, 2012.
-
11
Davis SL, Perri MB, Donabedian SM, et al: Epidemiology and outcomes of community-associated methicillin-resistant Staphylococcus aureus infection. J Clin Microbiol 45: 1705, 2007.
-
12
Labreche MJ, Lee GC, Attridge RT, et al: Treatment failure and costs in patients with methicillin-resistant Staphylococcus aureus (MRSA) skin and soft tissue infections: a South Texas Ambulatory Research Network (STARNet) study. J Am Board Fam Pract 26: 508, 2013.
-
13
Tattevin P, Schwartz BS, Graber CJ, et al: Concurrent epidemics of skin and soft tissue infection and bloodstream infection due to community-associated methicillin-resistant Staphylococcus aureus. Clin Infect Dis 55: 781, 2012.
-
14
Engemann JJ, Carmeli Y, Cosgrove SE, et al: Adverse clinical and economic outcomes attributable to methicillin resistance among patients with Staphylococcus aureus surgical site infection. Clin Infect Dis 36: 592, 2003.
-
15
Itani KM, Merchant S, Lin SJ, et al: Outcomes and management costs in patients hospitalized for skin and skin-structure infections. Am J Infect Control 39: 42, 2011.
-
16
Lipsky BA, Weigelt JA, Gupta V, et al: Skin, soft tissue, bone, and joint infections in hospitalized patients: epidemiology and microbiological, clinical, and economic outcomes. Infect Control Hosp Epidemiol 28: 1290, 2007.
-
17
Ostermann H, Blasi F, Medina J, et al: Resource use in patients hospitalized with complicated skin and soft tissue infections in Europe and analysis of vulnerable groups: the REACH study. J Med Econ 17: 719, 2014.
-
18
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 52: e18, 2011.
-
19
Hawser SP, Bouchillon SK, Hoban DJ, et al: Rising incidence of Staphylococcus aureus with reduced susceptibility to vancomycin and susceptibility to antibiotics: a global analysis 2004-2009. Int J Antimicrob Agents 37: 219, 2011.
-
20
[No author listed.] Sivextro [package insert]. Whitehouse Station, NJ: Merck & Co, 2015.
-
21
[No author listed.] Sivextro [package insert]. Surrey, United Kingdom: Cubist UK Ltd, 2015.
-
22
[No author listed.] Health Canada. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2015_sivextro_173603-eng.php. Updated November 19, 2015. Accessed May 2, 2016.
-
23
Flanagan S, Fang E, Munoz KA, et al: Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Pharmacotherapy 34: 891, 2014.
-
24
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 53: 3236, 2009.
-
25
Brown SD, Traczewski MM: Comparative in vitro antimicrobial activities of torezolid (TR-700), the active moiety of a new oxazolidinone, torezolid phosphate (TR-701), determination of tentative disk diffusion interpretive criteria, and quality control ranges. Antimicrob Agents Chemother 54: 2063, 2010.
-
26
Thomson KS, Goering RV: Activity of tedizolid (TR-700) against well-characterized methicillin-resistant Staphylococcus aureus strains of diverse epidemiological origins. Antimicrob Agents Chemother 57: 2892, 2013.
-
27
Flanagan S, Minassian SL, Morris D, et al: Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother 58: 6471, 2014.
-
28
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 309: 559, 2013.
-
29
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 14: 696, 2014.
-
30
Shorr AF, Lodise TP, Corey GR et al. : Analysis of the Phase 3 ESTABLISH Trials: Tedizolid versus linezolid in acute bacterial skin and skin structure infection. Antimicrob Agents Chemother 59: 864, 2014.
-
31
Itani KM, Shorr AF: FDA guidance for ABSSSI trials: implications for conducting and interpreting clinical trials. Clin Infect Dis 58(suppl 1): S4, 2014.
-
32
European Medicines Agency: Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. Available at: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500153953. Accessed May 2, 2016.
-
33
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 58: 7198, 2014.
-
34
Shaw KJ, Barbachyn MR: The oxazolidinones: past, present, and future. Ann N Y Acad Sci 1241: 48, 2011.
-
35
De Vriese AS, Coster RV, Smet J, et al: Linezolid-induced inhibition of mitochondrial protein synthesis. Clin Infect Dis 42: 1111, 2006.
-
36
[No author listed.] Zyvox [package insert]. New York, NY. Pfizer, Inc, 2015.
-
37
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 59: 178, 2015.
Tedizolid and Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections of the Lower Extremity versus Non–Lower-Extremity Infections
Pooled Analysis of Two Phase 3 Trials
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Background:
Tedizolid phosphate, the prodrug of the oxazolidinone tedizolid, has been approved in a number of countries, including the United States, those in the European Union, and Canada, for treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Two phase 3 trials demonstrated the noninferior efficacy of tedizolid (200 mg once daily for 6 days) to linezolid (600 mg twice daily for 10 days) in patients with ABSSSI. Because of the challenges of treating lower-extremity ABSSSI, the efficacy and safety of tedizolid and linezolid for treating lower-extremity versus non–lower-extremity infections were compared.
Methods:
This was a post hoc analysis of pooled data from patients with lower-extremity infections enrolled in two phase 3 studies, ESTABLISH-1 (NCT01170221) and ESTABLISH-2 (NCT01421511), comparing tedizolid to linezolid in patients with ABSSSI.
Results:
Lower-extremity ABSSSI were present in 40.7% of tedizolid-treated and 42.2% of linezolid-treated patients. Methicillin-resistant Staphylococcus aureus (MRSA) was present in 34.7% of all patients with a baseline causative pathogen. Early clinical responses at 48 to 72 hours and investigator-assessed responses at the post-therapy evaluation were similar between tedizolid and linezolid, regardless of ABSSSI type. With both treatments, the early clinical response was slightly higher in patients with non–lower-extremity infection than in those with lower-extremity ABSSSI (tedizolid, 84.8% versus 77.0%; linezolid, 81.4% versus 76.6%, respectively); however, by the post-therapy evaluation visit, response rates were similar (tedizolid, 87.1% versus 86.3%; linezolid, 86.6% versus 87.2%, respectively). Gastrointestinal adverse events and low platelet counts were observed more frequently with linezolid treatment.
Conclusions:
Post-therapy evaluations showed that the clinical response of lower-extremity ABSSSI to tedizolid and linezolid was comparable to that of ABSSSI in other locations. A short 6-day course of once-daily tedizolid was as effective as a 10-day course of twice-daily linezolid in treating patients with lower-extremity ABSSSI.
