This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Version: May 15, 2012
Prepared for: Antimicrobial Agents and Chemotherapy
1
Comparative Efficacy of Human Simulated Exposures of Tedizolid and Linezolid against 2
Staphylococcus aureus in the Murine Thigh Infection Model 3
4
R. A. Keel1, P. R. Tessier2, J. L. Crandon2, D. P. Nicolau2 5
1California Northstate College of Pharmacy, Rancho Cordova, CA, 2Center for Anti-6
Infective Research and Development, Hartford Hospital, Hartford 7
Running title: Comparative efficacy of tedizolid and linezolid (character and space 8
1. Andes, D., M. L. van Ogtrop, J. Peng, and W. A. Craig. 2002. In vivo 236 pharmacodynamics of a new oxazolidinone (Linezolid). Antimicrob Agents 237 Chemother. 46(11):3484-3489. 238
2. Bien P., K. A. Munoz, J. Bohn, R. Wright, C. Bethune, and P. Prokocimer. 239 2008. Human Pharmacokinetics of TR-700 after ascending single oral doses 240 of the prodrug TR-701, a novel oxazolidinone antibiotic. Abstr., 48th Intersci. 241 Conf. Antimicrob. Agents Chemother. Abstr F1-2063. 242
3. Brown, S. D., and M. M. Traczewski. 2010. Comparative in vivo 243 antimicrobial activities of torezolid (TR-700), the active moiety of a new 244 oxazolidinone, torezolid phosphate (TR-701), determination of tentative disk 245 diffusion interpretative criteria, and quality control ranges. Antimicrob. Agents 246 Chemother. 54(5):2063-2069. 247
4. Buerger C., N. Plock, P. Dehghanyar, C. Joukhadar, and C. Kloft. 2006. 248 Pharmacokinetics of unbound linezolid in plasma and tissue interstitium of 249 critically ill patients after multiple dosing using microdialysis. Antimicrob. 250 Agents Chemother. 50:2455-2463. 251
5. Clinical and Laboratory Standards Institute (CLSI). 2009. Methods for 252 dilution antimicrobial susceptibility tests for bacteria that grow aerobically 253 approved standard, 8th edition. M07-A8. Clinical and Laboratory Standards 254 Institute, Wayne, PA. 255
6. De Anda, C., Das, A., Fang, E. and P. Prokocimer. 2011. Acute Bacterial 256 Skin and Skin Structure Infection (ABSSI) Dose-Ranging Phase 2 Tedizolid 257 Phosphate (TR-701) Study: Assessment of Efficacy with New FDA Guidance. 258 Abstr 51st Intersci. Conf. Antimicrob Agents Chemother. abstr L1-1496. 259
7. Drusano, G. L., C. Fregeau, W. Liu, H. Conde, R. Kulawy, and Louie, A. 260 2011. Impact of granulocytes on the antimicrobial effect of Tedizolid in a 261 mouse thigh infection model. Antimicrob. Agents Chemother. 55(11):5300-262 5305. 263
8. Hidayat, L. K., H. Dl, R. Quist, K. A. Shriner, and A. Wong-Beringer. 264 2006. Highdose vancomycin therapy for methicillin-resistant Staphylococcus 265 aureus infections: efficacy and toxicity. Arch Intern Med. 166:2138–2144. 266
9. Housman, S. T., J. S. Pope, J. Russomanno, E. Salerno, E. Shore, J. L. 267 Kuti, and D. P. Nicolau. 2011. Pulmonary disposition of torezolid following 268 200mg once-daily oral tedizold phosphate in healthy volunteers. Abstr. 51st 269 Intersci. Conf. Antimicrob. Agents Chemother. Abstr.A1-1747. 270
10. Howden, B. P., P. B. Ward, P. G. Charles, T. M. Korman, A. Fuller, P. du 271 Cros, E. A. Grabsch, S. A. Roberts, J. Robson, K. Read, N. Bak, J. 272 Hurley, P. D. Johnson, A. J. Morris, B. C. Mayall, and M. L. Grayson. 273 2004. Treatment outcomes for serious infections caused by methicillin-274 resistant Staphylococcus aureus with reduced vancomycin susceptibility. Clin 275 Infect Dis 38:521–528. 276
11. Hsu, D.I., L. K. Hidayat, R. Quist, J. Hindler, A. Karlsson, A. Yusof, and A. 277 Wong-Beringer. 2008. Comparison of method-specific vancomycin minimum 278 inhibitory concentration values and their predictability for treatment outcome 279
of methicillin-resistant Staphylococcus aureus(MRSA) infections. Int J 280 Antimicrob Agents. 32:378–385. 281
12. Jones, R. N., G. J. Moet, H. S. Sader, R. E. Mendes, and M. Castanheira. 282 2009. TR-700 in vitro activity against and resistance mutation frequencies 283 among Gram-positive pathogens. J. Antimicrob. Chemother. 63:716-720. 284
13. Jones, R. N. 2006. Microbiological features of vancomycin in the 21st 285 century: minimum inhibitory concentration creep, bactericidal/static activity, 286 and applied breakpoints to predict clinical outcomes or detect resistant 287 strains. Clin. Infect. Dis. 42:S13–S24. 288
14. LaPlante, K. L., S. L. Leonard, D. R. Andes, W. A. Craig, and M. J. Rybak. 289 2008. Activities of clindamycin, daptomycin, doxycycline, linezolid, 290 trimethoprim-sulfamethoxazole, and vancomycin against community-291 associated methicillin-resistant Staphylococcus aureus with inducible 292 clindamycin resistance in murine thigh infection and in vitro 293 pharmacodynamic models. Antimicrob Agents Chemother. 52(6):2156-2162. 294
15. Livermore, D. M., S. Mushtaq, M. Warner, and N. Woodford. 2009. Activity 295 of oxazolidinone TR-700 against linezolid –susceptible and –resistant 296 staphylococci and enterococci. J. Antimicrob Chemother. 63:713-715. 297
16. Locke, J. B., M. Hilgers, and K. J. Shaw. 2009. Novel ribosomal mutations 298 in Staphylococcus aureus strains identified through selection with the 299 oxazolidinones linezolid and torezolid (TR-700). Antimicrob. Agents 300 Chemother. 53(12):5265-5274. 301
17. Locke, J. B., M. Hilgers, and K. J. Shaw. 2009. Mutations in ribosomal 302 protein L3 are associated with oxazolidinone resistance in Staphylococci of 303 clinical origin. Antimcrob. Agents Chemother. 53(12):5275-5278. 304
18. Locke, J. B., J. Finn, M. Hilgers, G. Morales, S. Rahawi, G. C. Kedar, J. J. 305 Picazo, W. Im, K. J. Shaw, and J. L. Stein. 2010. Structure-activity 306 relationships of diverse oxazolidinones for linezolid-resistant Staphylococcus 307 aureus strains possessing the cfr methyltransferase gene or ribosomal 308 mutations. Antimicrob. Agents. Chemother. 54(12):5337-5343. 309
19. Louie, A., W. Lui, R. Kulawy, and G. L. Drusano. 2011. In vivo 310 pharmacodynamics of torezolid phosphate (TR-701), a new oxazolidinone 311 antibiotic, against methicillin-susceptible and methicillin-resistant 312 Staphylococcus aureus strains in a mouse thigh infection model. Antimicrob. 313 Agents Chemother. 55(7):3453-3460. 314
20. Louie, A., C. Fregeau, W. Liu, H. Conde, R. Kulawy, and G. L. Drusano. 315 2009. Defining the impact of granulocytes on the kill of methicillin-resistant 316 Staphyloccocus aureus (MRSA) by the new oxazolidinone prodrug TR-701. 317 Abstr. 49th Intersci. Conf. Antimicrob. Agents Chemother. Abstr. A1-1935. 318
21. MacGowan, A. P. 2003. Pharmacokinetic and pharmacodynamic profile of 319 linezolid in healthy volunteers and patients with Gram-positive infections. J. 320 Antimicrob. Chemother. 51(S2):ii17-ii25. 321
22. Mason, E. O., L. B. Lamberth, W. A. Hammerman, K. G. Hulten, J. 322 Versalovic, and S. L. Kaplan. 2009. Vancomycin MICs for Staphylococcus 323 aureus vary by detection method and have subtly increased in a pediatric 324 population since 2005. J Clin. Microbiol. 47:1628–1630. 325
23. Meager A. K., A. Forrest, C. R. Rayner, M. C. Birmingham, and J. J. 326 Schentag. 2003. Population pharmacokinetics of linezolid in patients treated 327 in a compassionate-use program. Antimicrob. Agents Chemother. 47:548-328 553. 329
24. Neoh, H., S. Hori, M. Komatsu, T. Oguri, F. Takeuchi, L. Cui, and K. 330 Hiramatsu. 2007. Impact of reduced vancomycin susceptibility on the 331 therapeutic outcome of MRSA bloodstream infections. Ann Clin Microbiol 332 Antimicrob. 6:13. 333
25. Pichereau, S., J. Bohrmuller, K. Marchillo, T. Stamstad, W. Craig, and D. 334 Andes. 2009. Comparative pharmacodynamics of novel oxazolidinone, 335 torezolid phosphate (TR-701), against S. aureus in the neutropenic murine 336 pneumonia model. Abstr 49th Instersci. Conf. Antimicrob Agents Chemother. 337 abstr A1-1939. 338
26. Prokocimer P., P. Bien, J. Surber, P. Mehra, C. DeAnda, J. B. Bulitta, and 339 G. R. Corey. 2011. Phase 2, randomized, double-blind, dose-ranging study 340 evaluating the safety, tolerability, population pharmacokinetics, and efficacy of 341 oral torezolid phosphate in patients with complicated skin and skin structure 342 infections. Antimicrob Agents Chemother. 55(2):583-592. 343
27. Rayner, C. R., A. Forrest, A. K. Meagher, M. C. Birmingham, and J. J. 344 Schentagg. 2003. Clinical pharmacodynamics of linezolid in seriously ill 345 patients treated in a compassionate use programme. Clin. Pharmacokinet. 346 42(15):1411-1423. 347
28. Rhee, K. Y., D. F. Gardiner, and M. Charles. 2005. Decreasing in-vitro 348 susceptibility of clinical Staphylococcus aureus isolates to vancomycin at the 349 New York Hospital: quantitative testing redux. Clin. Infect. Dis. 40:1705–1706. 350
29. Rybak, M., B. Lomaestro, J. C. Rotschafer, R. Moellering, W. Craig, M. 351 Billeter, J. R. Dalovisio, and D. P. Levine. 2009. Therapeutic monitoring of 352 vancomycin in adult patients: a consensus review of the American Society of 353 Health-System Pharmacists, the Infectious Diseases Society of America, and 354 the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm 355 66:82–98. 356
30. Sader, H. S.,P. D. Fey, D. N. Fish, A. P. Limaye, G. Pankey, J. Rahal, M. 357 J. Rybak, D. R. Snydman, L. L. Steed, K. Waites, and R. N. Jones. 2009. 358 Evaluation of vancomycin and daptomycin potency trends (MIC creep) 359 against methicillin-resistant Staphylococcus aureus isolates collected in nine 360 U.S. medical centers from 2002 to 2006. Antimicrob. Agents Chemother. 361 53:4127–4132. 362
31. Schaadt, R., D. Sweeney, D. Shinabarger, and G. Zurenko. 2009. In vitro 363 activity of TR-700, the active ingredient of the antibacterial prodrug TR-701, a 364 novel oxazolidinone antibacterial agent. Antimicrob. Agents Chemother. 365 53(8):3236-3239. 366
32. Shaw, K. J., S. Poppe, R. Schaadt, V. Brown-Driver, J. Finn, C. M. Pillar, 367 D. Shinabarger, G. Zurenko. 2008. In vitro activity of TR-700, the 368 antibacterial moiety of the prodrug TR-701, against linezolid-resistant strains. 369 Antimicrob. Agents Chemother. 52(12):4442-4447. 370
33. Soriano, A., F. Marco, J. A. Martinez, E. Pisos, M. Almela, V. P. Dimova , 371 D. Alamo, M. Ortega, J. Lopez, and J. Mensa. 2008. Influence of 372 vancomycin minimum inhibitory concentration on the treatment of methicillin 373 resistant Staphylococcus aureus bacteremia. Clin Infect Dis 46:193–200. 374
34. Steinkraus, G., R. White, L. Friedrich. 2007.Vancomycin MIC creep in non–375 vancomycin-intermediate Staphylococcus aureus (VISA), vancomycin 376 susceptible clinical methicillin-resistant S. aureus (MRSA) blood isolates from 377 2001–05. J. Antimicrob. Chemother. 60:788–794. 378
35. Stevens, D. L., et al. 2005. Practice guidelines for the diagnosis and 379 management of skin and soft-tissue infections. Clin. Infect. Dis. 41:1373–380 1406. 381
36. Tobin, C. M., Sunderland, J., White, L. O. and A. P. MacGowan. 2001. A 382 Simple, Isocratic High-Performance Liquid Chromatography Assay for 383 Linezolid in Human Serum. J Antimicrob. Chemother. 48:605-608. 384