Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: The ESTABLISH-1 randomized trial

JAMA

Volumn 309, Issue 6, 2013, Pages 559-569

  Prokocimer, Philippe ^a   De Anda, Carisa ^a   Fang, Edward ^a   Mehra, Purvi ^b   Das, Anita ^c  

^a Trius Therapeutics Inc   (United States)

^b eStudy Site   (United States)

^c AxiStat Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LINEZOLID; TEDIZOLID;

ABSCESS; ADULT; ARTICLE; BACTERIAL SKIN DISEASE; BACTERIUM ISOLATION; CELLULITIS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; EUROPE; FEMALE; HUMAN; INTENTION TO TREAT ANALYSIS; LIMB DISEASE; MAJOR CLINICAL STUDY; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; MOUTH TEMPERATURE; MULTICENTER STUDY; NAUSEA; NORTH AMERICA; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOUTH AND CENTRAL AMERICA; TREATMENT DURATION; VOMITING;

EID: 84873642637     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2013.241     Document Type: Article

References (35)

1. Shaw KJ, Barbachyn MR. The oxazolidinones: past, present, and future. Ann N Y Acad Sci. 2011;1241(1):48-70.
2. LoVecchio F, Perera N, Casanova L, Mulrow M, Pohl A. Board-certified emergency physicians' treatment of skin and soft tissue infections in the community-acquired methicillin-resistant Staphylococcus aureus era. Am J Emerg Med. 2009;27(1):68-70.
3. Klein E, Smith DL, Laxminarayan R. Community-associated methicillin-resistant Staphylococcus aureus in outpatients, United States, 1999-2006. Emerg Infect Dis. 2009;15(12):1925-1930.
4. Reyes J, Rincón S, Díaz L, et al. Dissemination of methicillin-resistant Staphylococcus aureus USA300 sequence type 8 lineage in Latin America. Clin Infect Dis. 2009;49(12):1861-1867.
5. Napolitano LM. Early appropriate parenteral antimicrobial treatment of complicated skin and soft tissue infections caused by methicillin-resistant Staphylococcus aureus. Surg Infect (Larchmt). 2008;9(suppl 1):s17-s27.
6. Sievert DM, Rudrik JT, Patel JB, McDonald LC, Wilkins MJ, Hageman JC. Vancomycin-resistant Staphylococcus aureus in the United States, 2002-2006. Clin Infect Dis. 2008;46(5):668-674.
7. Boucher HW, Corey GR. Epidemiology of methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2008;46(suppl 5):S344-S349.
8. Bishop E, Melvani S, Howden BP, Charles PGP, Grayson ML. Good clinical outcomes but high rates of adverse reactions during linezolid therapy for serious infections: a proposed protocol for monitoring therapy in complex patients. Antimicrob Agents Chemother. 2006;50(4):1599-1602.
9. Minson Q, Gentry CA. Analysis of linezolid-associated hematologic toxicities in a large Veterans Affairs medical center. Pharmacotherapy. 2010;30(9):895-903.
10. Morales G, Picazo JJ, Baos E, et al. Resistance to linezolid is mediated by the CFR gene in the first report of an outbreak of linezolid-resistant Staphylococcus aureus. Clin Infect Dis. 2010;50(6):821-825.
11. Pfizer. Zyvox (linezolid injection) [package insert]. http://labeling.pfizer.com/ShowLabeling.aspx?id=649. Accessed October 21, 2012.
12. US Food and Drug Administration. Ceftaroline fosamil for the treatment of community-acquired bacterial pneumonia and complicated skin and skin structure infections, US FDA briefing document for anti-infective drugs advisory committee meeting on September 7, 2010. http://www.fda.gov/downloads/advisorycommittees/ committeesmeetingmaterials/drugs/anti-infectivedrugsadvisorycommittee/ucm224656. pdf. Accessed October 21, 2012.
13. US Food and Drug Administration. Guidance for industry: acute bacterial skin and skin structure infections - developing antimicrobial drugs for treatment. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071185.pdf. Accessed October 21, 2012.
14. 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.
15. 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.
16. Langemo D, Anderson J, Hanson D, Hunter S, Thompson P. Measuring wound length, width, and area: which technique? Adv Skin Wound Care. 2008;21(1):42-45.
17. Talbot GH, Powers JH, Fleming TR, Siuciak JA, Bradley J, Boucher H; CABP-ABSSSI Project Team. Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin Infect Dis. 2012;55(8):1114-1121.
18. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990;9(12):1447-1454.
19. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404-413.
20. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4(2):213-226.
21. Westfall PH, Krishen A. Optimally weighted, fixed sequence and gatekeeper multiple testing procedures. J Statist Planning Infer. 2001;99:25-41.
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. Flanagan S, Minassian S, Fang E, et al. Lack of MAO inhibition by tedizolid phosphate in clinical and nonclinical studies. Presented at: 52nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; September 9-12, 2012; San Francisco, CA. Abstract A-1295a.
24. Snodgrass WR, Anderson T. Sulphanilamide in the treatment of erysipelas. Br Med J. 1937;2(4014):1156-1159.
25. Snodgrass WR, Anderson T. Prontosil in erysipelas. Br Med J. 1937;2(3993):101-104.
26. Corey GR, Stryjewski ME. New rules for clinical trials of patients with acute bacterial skin and skin-structure infections: do not let the perfect be the enemy of the good. Clin Infect Dis. 2011;52(suppl 7):S469-S476.
27. Spellberg B, Talbot GH, Boucher HW, et al; Antimicrobial Availability Task Force of the Infectious Diseases Society of America. Antimicrobial agents for complicated skin and skin-structure infections: justification of noninferiority margins in the absence of placebo-controlled trials. Clin Infect Dis. 2009;49(3):383-391.
28. Drusano GL. Early endpoints for acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2012;56(5):2221-2222.
29. Pohlman J. Cross-discipline team leader review NDA application number: 200327. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2010/ 200327Orig1s000CrossR.pdf. Accessed October 21, 2012.
30. Toerner JG, Burke L, Komo S, Papadopoulos E. A collaborative model for endpoint development for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Clin Infect Dis. 2012;55(8):1122-1123.
31. Corey GR, Wilcox M, Talbot GH, et al. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010;51(6):641-650.
32. Covington P, Davenport JM, Andrae D, et al. Randomized, double-blind, phase II, multicenter study evaluating the safety/tolerability and efficacy of JNJ-Q2, a novel fluoroquinolone, compared with linezolid for treatment of acute bacterial skin and skin structure infection. Antimicrob Agents Chemother. 2011;55(12):5790-5797.
33. Dunne M, Mehra P, Green S, et al. A study to assess skin lesion measurement techniques related to acute bacterial skin and skin structure infections. Presented at: Infectious Diseases Week; October 17-21, 2012; San Diego, CA. Abstract 1624.
34. Corwin P, Toop L, McGeoch G, et al. Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital. BMJ. 2005;330(7483):129.
35. Eron LJ, Passos S. Early discharge of infected patients through appropriate antibiotic use. Arch Intern Med. 2001;161(1):61-65.