Doripenem: a New Carbapenem Antimicrobial | CMAC

Doripenem: a New Carbapenem Antimicrobial

Clinical Microbiology and Antimicrobial Chemotherapy. 2008; 10(3):245-259

​ Stetsiouk O.U., Andreeva I.V., Kozlov R.S.
carbapenems doripenem activity
Section
Antimicrobials
Type
Journal article
Publication
Clinical Microbiology and Antimicrobial Chemotherapy. 2008; 10(3):245-259

Abstract

There is a clinical need for newer effective antimicrobials that would overcome resistance mechanisms across a wide range of microorganisms. Doripenem is a novel promising carbapenem antimicrobial, which was approved by Food and Drug Administration in October, 2007. It is expected to be approved in Russia in 2008. Doripenem has a broad spectrum of activity against Gram-positive, Gram-negative (including multiresistant strains), and anaerobic bacteria. Compared to other antipseudomonal antimicrobials (imipenem and meropenem), doripenem has higher in vitro activity against some of Gram-negative microorganisms (including P. aeruginosa). Clinical trials have demonstrated that doripenem was effective and well tolerated agent in patients with complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), urinary tract infections (UTI) as well as hospital-acquired pneumonia (including ventilator-associated pneumonia). Efficacy and safety of doripenem are also being evaluated in other infections caused by P. aeruginosa.

  • 1. Zhanel G.G., Wiebe R., Dilay L., Thompson K., Rubinstein E., Hoban D.J., et al. Comparative review of the carbapenems. Drugs 2007; 67(7):1027-52.
  • 2. Галкин Д.В. Карбапенемы через 20 лет после открытия: современные микробиологические и клинические аспекты. Клин микробиол антимикроб химиотер 2007; 9 (2):133-52.
  • 3. Hagerman J.K., Knechtel S.A., Klepser M.E. Doripenem: a new extended-spectrum carbapenem antibiotic. Formulary 2007; 42:676-88.
  • 4. FDA approves new drug to treat complicated urinary tract and intra-abdominal infections. FDA news (October, 17, 2007). Available from: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01728.html
  • 5. Norrby S.R. Carbapenems. Med Clin North Am 1995; 79:745-59.
  • 6. Mushtaq S., Ge Y., Livermore D.M. Comparative activities of doripenem versus isolates, mutants, and transconjugants of Enterobacteriaceae and Acinetobacter spp. with characterized beta-lactamases. Antimicrob. Agents Chemother 2004; 48:1313-19.
  • 7. Tsuji M., Ishii Y., Ohno A., Miyazaki S., Yamaguchi K. In vitro and in vivo antibacterial activities of S-4661, a new carbapenem. Antimicrob Agents Chemother 1998; 42:94-9.
  • 8. Iso Y., Irie T., Nishino Y., Motokawa K., Nishitani Y. A novel 1-beta-methylcarbapenem antibiotic, S-4661. Synthesis and structure-activity relationships of 2-(5- substituted pyrrolidine-3-ylthio)-1 beta-methylcarbapenems. J Antibiot 1996; 49:199-209.
  • 9. Jones R.N., Huynh H.K., Biedenbach D.J. Activities of doripenem (S-4661) against drug-resistant clinical pathogens. Antimicrob Agents Chemother 2004; 48:3136-40.
  • 10. Birnbaum J., Kahan F.M., Kropp H. et al. Carbapenems, a new class of beta-lactam antibiotics. Discovery and development of imipenem/cilastatin. Am J Med 1985; 787:3-21.
  • 11. Fritsche T.R., Stilwell M.G., Jones R.N. Antimicrobial activity of doripenem (S-4661): A global surveillance report (2003). Clin Microbiol Infect 2005; 11:974-84.
  • 12. Wexler H.M., Engel A.E., Glass D., Li C. In vitro activities of doripenem and comparator agents against 364 anaerobic clinical isolates. Antimicrob Agents Chemother 2005; 49:4413-17.
  • 13. Jones R.N., Huynh H.K., Biedenbach D.J., Fritsche T.R., Sader H.S. Doripenem (S-4661), a novel carbapenem: Comparative activity against contemporary pathogens including bactericidal action and preliminary in vitro methods evaluations. J Antimicrob Chemother 2004; 54:144-54.
  • 14. Bell J.M., Fritsche T.R., Jones R.N., Turnidge J.D. Doripenem activity tested against gram-negative pathogens in the Asia-Pacific (APAC) region: Report from the SENTRY Antimicrobial Surveillance Program (2006). In: Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 15. Goldstein E.J.C., Citron D.M., Merriam C.V., Warren Y.A., Tyrrell K.L., Fernandez H.T. In vitro activity of doripenem against aerobic and anaerobic bacteria isolated from infected diabetic foot wounds. In: Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 16. Pillar C.M., Aranza-Torres M.K., Shah D., Sahm D.F. Analysis of doripenem activity, relative to other carbapenems, against target gram-negative pathogens isolated from specific infection sites. In: Program and abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 17. Jones R.N., Sader H.S., Fritsche T.R. Comparative activity of doripenem and three other carbapenems tested against Gram-negative bacilli with various beta-lactamase resistance mechanisms. Diagn Microbiol Infect Dis 2005; 52:71-4.
  • 18. Traczewski M.M., Brown S.D. In vitro activity of doripenem against Pseudomonas aeruginosa and Burkholderia cepacia isolates from both cystic fibrosis and non-cystic fibrosis patients. Antimicrob Agents Chemother 2006; 50:819-21.
  • 19. Chen Y., Garber E., Zhao Q., et al. In vitro activity of doripenem (S-4661) against multidrug-resistant gramnegative bacilli isolated from patients with cystic fibrosis. Antimicrob Agents Chemother 2005; 49:2510-11.
  • 20. Aranza-Torres M.K., Pillar C.M., Shah D., Sahm D. Stratified analysis of doripenem activity against Enterobacteriaceae and Pseudomonas aeruginosa according to patient location: Inpatients and ICU patients. In: Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 21. Queenan A.M., Shang W., Bush K., Flamm R. Hydrolysis parameters for doripenem, meropenem, and imipenem tested with b-lactamases of molecular classes A to D. In: Program and Abstracts of the 18th European Congress of Clinical Microbiology and Infectious Diseases, April 19- 22, 2008, Barcelona, Spain,
  • 22. Shimada J., Yamaguchi K., Shiba T., Saito A., Shuden S., et al. A new carbapenem antibiotic for injection: characteristics of doripenem. Jpn J Antibiot 2005; 58:489-506.
  • 23. Huynh H.K., Biedenbach D.J., Jones R.N. Delayed resistance selection for doripenem when passaging Pseudomonas aeruginosa isolates with doripenem plus an aminoglycoside. Diagn Microbiol Infect Dis 2006; 55:241-3.
  • 24. Biedenbach D.J., Moet G.J., Jones R.N. Occurrence and antimicrobial resistance pattern comparisons among bloodstream infection isolates from the SENTRY Antimicrobial Surveillance Program (1997-2002). Diagn Microbiol Infect Dis 2004; 50:59-69.
  • 25. Andrerson D.L. Doripenem. Drugs Today 2006; 42:399- 404.
  • 26. Brown N.P., Jones M.E., Draghi D.C., Crites E., et al. Profile of doripenem activity against gram-positive pathogens: results of a 2005-2006 surveillance initiative. In: Program and abstracts of the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2006.
  • 27. Sasaki S., Murakami K., Nishitani Y., Kuwahara S. S-4661, a new carbepenem: I. In vitro antibacterial activity. Abstr. F33. In: Program and Abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1994.
  • 28. Inoue K., Hamana Y., Iyobe S., Mitsuhashi S. Antibacterial activity of new carbapenem S-4661, and its stability to b-lactamase. Abstr. F112. In: Program and Abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1996.
  • 29. El Amin N., Giske C.G., Jalal S., et al. Carbapenem resistance mechanisms in Pseudomonas aeruginosa: alterations of porin OprD and efflux proteins do not fully explain resistance patterns observed in clinical isolates. APMIS 2005; 113:187-96.
  • 30. Kim A., Banevicius M.A., Nicolau D.P. In vivo efficacy of doripenem human-simulated exposures against Pseudomonas aeruginosa. In: Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 31. Bhavnani S.M., Hammel J.P., Cirincione B.B., Wikler M.A., Ambrose P.G. Use of pharmacokinetic-pharmacodynamic target attainment analyses to support phase 2 and 3 dosing strategies for doripenem. Antimicrob Agents Chemother 2005; 49:3944-47.
  • 32. Nishino T., Otsuki M., Izawa M. In vitro and in vivo antibacterial activity of S-4661, a new carbapenem antibiotic. Abstr. F115. In: Program and Abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1996.
  • 33. Totsuka K., Shiseki M., Uchiyama T., Shimizu K. In vitro postantibiotic effect and in vivo antibacterial activity of novel carbapenem, S-4661. Abstr. F113. In: Program and Abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1996.
  • 34. Kobayashi Y., Kizaki M., Mutou A., Synergy with S4661 and vancomycin or teicoplanin against imipenem-resistant MRSA identified by the PCR method. Abstr. F216. In: Program and Abstracts of the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1997.
  • 35. Mushtaq S., Warner M., Ge Y., Kaniga K., Livermore D.M. In vitro interactions of doripenem with other antibacterial agents. In: Program and Abstracts of the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2005.
  • 36. Mikamo H., Izumi K., Hua Y.H., Hayasaki Y., Sato Y., Tamaya T. In vitro and in vivo antibacterial activities of a new injectable carbapenem, S-4661 agains gynaecological pathogens. J Antimicrob Chemother 2000; 46(3):471- 4.
  • 37. Miwa H., Sasaki S., Shimada J., Kuwahara S. S-4661, a new carbapenem: II. In vivo antibacterial activity. Abstr. F35. In: Program and Abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1994.
  • 38. Horiuchi M., Kimura M., Tokumura M., Hasebe N., et al. Absence of convulsive liability of doripenem, a new carbapenem antibiotic, in comparison with -lactam antibiotics. Toxicology 2006; 222:114-24.
  • 39. Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing; seventeenths informational supplement. CLSI document M100-S17. 2007.
  • 40. CLSI. Performance standards for antimicrobial disk susceptibility tests; approved standard – ninths edition, CLSI document M2-A9. 2006.
  • 41. CLSI. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard – seventh edition. CLSI document M7-A7. 2006.
  • 42. CLSI. Methods for antimicrobial susceptibility testing of anaerobic bacteria; approved standard – sevenths edition. CLSI document M11-A7. 2007.
  • 43. Floren L.C., Wikler M.A., Kilfoil T., Ge Y. A phase 1 open-label controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of doripenem (DOR) administered intravenously to subjects with renal impairment. In: Program and Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2004.
  • 44. Thye D., Kilfoil T., Leighton A., Wikler M. Doripenem: A phase 1 study to evaluate safety, tolerability and pharmacokinetics in a western healthy volunteer population. Abstr. A-21. In: Program and Abstracts of the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2003.
  • 45. Floren L.C., Wikler M.A., Kilfoil T., Ge Y. A phase I, double-blind, placebo-controlled study to determine the safety, tolerability, and pharmacokinetics (PK) of prolonged-infusion regimens of doripenem (DOR) in healthy subjects. In: Program and abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2004.
  • 46. Nakashima M., Kato T., Kimura Y., Sasaki S., Konishi M., Oguma T. S-4661, a new carbapenem: IV. Pharmacokinetics in healthy volunteers. Abstr. F-39. In: Program and Abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1994.
  • 47. Nakashima M., Umemura K., Murakami M., Kimura Y., Oguma T. Pharmacokinetics of S-4661, new parenteral carbapenem antibiotic, 1000 mg multiple-dose administration in healthy male volunteers. Abstr. F-60. In: Program and Abstracts of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1998.
  • 48. Doribax [package insert]. Raritan, NJ: Ortho-McNeil Pharmaceutical Inc; 2007.
  • 49. Primaxin [package insert]. Whitehouse Station, NJ: Merck & Co; 2006.
  • 50. Merrem [package insert]. Wilmington, DE: AstraZeneca Corp; 2007.
  • 51. Shiba K., Nakashima M., Tanimura H., Okada H., Shimada J. Pharmacokinetics and pharmacodynamics of S-4661, new parenteral carbapenem antibiotic. Abstr. F-217. In: Program and Abstracts of the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 1997.
  • 52. Ikawa K., Morikawa N., Urakawa N., Ikeda K., Ohge H., Sueda T. Peritoneal penetration of doripenem after intravenous administration in abdominal-surgery patients. J Antimicrob Chemother 2007; 60:1395-97.
  • 53. Nakajima Y., Mizobuchi M., Nakamura M., et al. Mechanism of the drug interaction between valproic acid and carbapenem antibiotics in monkeys and rats. Drug Metab Dispos 2004; 32:1383-91.
  • 54. Naber K., Redman R., Kotey P., Llorens L., Kaniga K. Intravenous therapy with doripenem versus levofloxacin with an option for oral step-down therapy in the treatment of complicated urinary tract infections and pyelonephritis. Int J Antimicrob Agents 2007; 29(suppl 2): S212. Poster P833.
  • 55. Lucasti C., Jasovich A., Umeh O., Jiang J., Kaniga K. Treatment of complicated intra-abdominal infections: doripenem versus meropenem. Int J Antimicrob Agents 2007; 29(suppl 2):S212. Poster P834.
  • 56. Malafaia O., Umeh O., Jiang J. Doripenem versus meropenem for the treatment of complicated intraabdominal infections. In: Program and Abstracts of the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2006.
  • 57. Solomkin J., Umeh O., Jiang J., et al. Doripenem versus meropenem with an option for oral step-down therapy in treatment of complicated intra-abdominal infections. In: Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 58. Rea-Neto A., Niederman M., Lee M., Kaniga K., Prokocimer P., Friedland I. Efficacy and safety of intravenous doripenem vs. piperacillin/tazobactam in nosocomial pneumonia. In: Program and Abstracts of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); American Society for Microbiology, Washington D.C., 2007.
  • 59. Chastre J., Wunderink R., Prokocimer P., Lee M., Kaniga K., Friedland I. Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilatorassociated pneumonia: a multicenter, randomized study. Crit Care Med 2008; 36(4):1089-96.
  • 60. Horiuchi M., Kimura M., Tokumura M., Hasebe N., Arai T., Abe K. Absence of convulsive liability of doripenem, a new carbapenem antibiotic, in comparison with beta-lactam antibiotics. Toxicology 2006; 222:114-24.
  • 61. Psathas P.A., Kuzmission A., Ikeda K., Yasuo S. Stability of doripenem for injection (500 mg) in representative infusion fluids and containers. In: Program and Abstracts of 2007 American Society of Health-System Pharmacists Summer Meeting; June 24-27, 2007; San Francisco, CA.
  • 62. Invanz [package insert]. Whitehouse Station, NJ: Merck & Co; 2007.
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