Цефтаролин: накануне использования в России | КМАХ

Цефтаролин: накануне использования в России

Клиническая Микробиология и Антимикробная Химиотерапия. 2013; 15(3):212-218

​ Ортенберг Э.А.
цефтаролин цефалоспорины MRSA пневмония инфекции кожи и мягких тканей
Раздел
Антимикробные препараты
Тип
Журнальная статья
Публикация
Клиническая Микробиология и Антимикробная Химиотерапия. 2013; 15(3):212-218

Аннотация

Представлен обзор бактериологических и клинических данных о цефтаролине фосамиле — новом антибиотике цефалоспоринового ряда. Основные перспективы его использования в России связаны с высокой антипневмококковой и анти-MRSA активностью, широтой спектра антибактериального действия, низкой токсичностью и хорошей переносимостью.

  • 1. Infectious Diseases Society of America. The 10 x ‘20 initiative: pursuing a global commitment to develop 10 new antibacterial drugs by 2020. Clin Infect Dis 2010; 50(8):1081-3.
  • 2. Zhanel G.G., Sniezek G., Schweizer F., et al. Ceftaroline: A novel broad-spectrum cephalosporin with activity against meticillin-resistant Staphylococcus aureus. Drugs 2009; 69:809-31.
  • 3. Goodman J.J., Martin S.I. Critical appraisal of ceftaroline in the management of community-acquired bacterial pneumonia and skin infections. Ther Clin Risk Manag 2012; 8:149-56.
  • 4. Laudano J.B. Ceftaroline fosamil: a new broad-spectrum cephalosporin. J Antimicrob Chemother 2011; 66(3):iii11-iii18.
  • 5. Saravolatz L.D., Stein G.E., Johnson L.B. Ceftaroline: a novel cephalosporin with activity against Methicillinresistant Staphylococcus aureus. Clin Infect Dis 2011; 52(9):1156-63.
  • 6. Biek D., Critchley I.A., Riccobene T.A., Dirk A. Thye Ceftaroline fosamil: a novel broad-spectrum cephalosporin with expanded anti-Gram-positive activity. J Antimicrob Chemother 2010; 65(4):iv9-iv16.
  • 7. Drusano G.L. Pharmacodynamics of ceftaroline fosamil for complicated skin and skin structure infection: rationale for improved anti-methicillin-resistant Staphylococcus aureus activity. J Antimicrob Chemother 2010; 65(Suppl 4):iv33–iv39.
  • 8. Kosowska-Shick K., McGhee P.L., Appelbaum P.C. Affinity of ceftaroline and other β-lactams for penicillin-binding proteins from Staphylococcus aureus and Streptococcus pneumonia. Antimicrob Agents Chemother 2010; 54(5):1670-7.
  • 9. Villegas-Estrada A., Lee M., Hesek D, et al. Co-opting the cell wall in fighting methicillin-resistant Staphylococcus aureus: potent inhibition of PBP 2a by two anti-MRSA β-lactam antibiotics. J Am Chem Soc 2008; 130(29):9212-3.
  • 10. Saravolatz L., Pawlak J., Johnson L. In vitro activity of ceftaroline against community-associated methicillinresistant, vancomycin-intermediate, vancomycin-resistant, and daptomycin-nonsusceptible Staphylococcus aureus isolates. Antimicrob Agents Chemother 2010; 54(7):3027-30.
  • 11. Steed M., Vidaillac C., Rybak M.J. Evaluation of ceftaroline activity versus daptomycin (DAP) against DAPnonsusceptible methicillin-resistant Staphylococcus aureus strains in an in vitro pharmacokinetic/pharmacodynamic model. Antimicrob Agents Chemother 2011; 55(7):3522-6.
  • 12. McGee L., Biek D., Ge Y., et al. In Vitro evaluation of the antimicrobial activity of ceftaroline against cephalosporin-resistant isolates of Streptococcus pneumonia. Antimicrob Agents Chemother 2009; 53(2):552-6.
  • 13. Fenoll A., Aguilar L., Robledo O., et al. In vitro activity of ceftaroline against Streptococcus pneumoniae isolates exhibiting resistance to penicillin, amoxicillin, and cefotaxime. Antimicrob Agents Chemother 2008; 52(11):4209-10.
  • 14. Moisan H., Pruneau M., Malouin F. Binding of ceftaroline to penicillin-binding proteins of Staphylococcus aureus and Streptococcus pneumoniae. J Antimicrob Chemother 2010; 65(4):713-6.
  • 15. Ge Y., Biek D., Talbot G. H, Sahm D.F. In vitro profiling of ceftaroline against a collection of recent bacterial clinical isolates from across the United States. Antimicrob Agents Chemother 2008; 52(9):3398-3407.
  • 16. Jones R.N., Farrell D.J., Mendes R.E., Sader H.S Comparative ceftaroline activity tested against pathogens associated with community-acquired pneumonia: results from an international surveillance study. J Antimicrob Chemother 2011; 66(3):1769-80.
  • 17. Critchley I.A., Eckburg P.B., Jandourek A., et al. Review of ceftaroline fosamil microbiology: integrated FOCUS studies. J Antimicrob Chemother 2011; 66(3):iii45-iii51.
  • 18. Iizawa Y., Nagai J., Ishikawa T., et al. In vitro antimicrobial activity of T-91825, a novel anti-MRSA cephalosporin, and in vivo anti-MRSA activity of its prodrug, TAK-599. J Infect Chemother 2004; 10(3):146-56.
  • 19. Citron D. M., Tyrell K. L., Merriam C. V., Goldstein E.J.C. In vitro activity of ceftaroline against 623 diverse strains of anaerobic bacteria. Antimicrob Agents Chemother 2010, 54:1627-32.
  • 20. Jones R.N., Mendes R.E., Sader H.S. Ceftaroline activity against pathogens associated with complicated skin and skin structure infections: results from an international surveillance study. J Antimicrob Chemother 2010; 65(Suppl 4):iv17–iv31.
  • 21. Richter S.S., Heilmann K.P., Dohrn C.L, et al. Activity of ceftaroline and epidemiologic trends in Staphylococcus aureus isolates collected from 43 medical centers in the United States in 2009. Antimicrob Agents Chemother 2011; 55(9):4154-60.
  • 22. Doern G.V., Diekema D.J, Heilmann K.P., et al. In vitro activity of ceftaroline against clinical isolates of Streptococcus pneumoniae recovered in 43 U.S. medical centers during 2010-2011. Antimicrob Agents Chemother 2012; 56(6):3406-8.
  • 23. Козлов Р.С., Кречикова О.И., Сивая О.В. и соавт. Антимикробная резистентность Streptococcus pneumoniae в России: результаты проспективного многоцентрового исследования (фаза А проекта ПеГАС-I). Клиническая Микробиология и Антимикробная Химиотерапия 2002; 4(3):267-77.
  • 24. Karlowsky J.A., Adam H.J., DeCorby M.R., et al. In vitro activity of ceftaroline against Gram-positive and Gramnegative pathogens isolated from patients in canadian hospitals in 2009. Antimicrob Agents Chemother 2011; 55(6):2837-46.
  • 25. Flamm R.K., Sader H.S., Farrell D.J., Jones R.N. Summary of ceftaroline activity against pathogens in the United States, 2010: report from the assessing worldwide antimicrobial resistance evaluation (AWARE) surveillance program. Antimicrob Agents Chemother 2012; 56(6):2933-40.
  • 26. Richter S.S., Satola S.W., Crispell E.K., et al. Detection of Staphylococcus aureus isolates with heterogeneous intermediate-level resistance to vancomycin in the United States. J Clin Microbiol 2011; 49(12):4203-7.
  • 27. Zhanel G.G., Rossnagel E., Nichol K., et al. Ceftaroline pharmacodynamic activity versus community-associated and healthcare-associated methicillin-resistant Staphylococcus aureus, heteroresistant vancomycinintermediate S. aureus, vancomycin-intermediate S. aureus and vancomycin-resistant S. aureus using an in vitro model. J Antimicrob Chemother 2011; 66:1301-5.
  • 28. Corey G.R., Wilcox M.H., Talbot G.H., et al. CANVAS 1: the first phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65 (Suppl 4):iv53-iv65.
  • 29. Wilcox M.H., Corey G.R., Talbot G.H., et al. CANVAS 2: the second phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65 (Suppl 4):iv53- iv65.
  • 30. Corey G.R., Wilcox M.H., Talbot G.H., 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. Clinical Infectious Diseases 2009; 51:6641-50.
  • 31. Friedland H.D., O’Neal T., Biek D., et al. CANVAS 1 and 2: analysis of clinical response at day 3 in two phase 3 trials of ceftaroline fosamil versus vancomycin plus aztreonam in treatment of acute bacterial skin and skin structure infections. Antimicrob Agents Chemother 2012; 56(5):2231-6.
  • 32. Talbot G.H., Thye D., Das A., Ge Y. Phase 2 study of ceftaroline versus standard therapy in treatment of complicated skin and skin structure infections. Antimicrob Agents Chemother 2007; 51(10):3612-6.
  • 33. Tong A., Tong S.Y., Zhang Y., et al. Panton-valentine leukocidin is not the primary determinant of outcome for Staphylococcus aureus skin infections: evaluation from the CANVAS studies. PLoS one. 2012; 7(5):e37212.
  • 34. File T.M., Low D.E., Eckburg P.B., et al. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother 2011; 66 (suppl 3):iii 19-iii 32.
  • 35. Low D.E., File T.M., Eckburg P.B., et al. FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother 2011; 66 (suppl 3):iii33-iii44.
  • 36. File T.M., Low D.E., Eckburg P.B., et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubledblinded, multicenter Phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. Clin Infect Dis 2010; 51:1395-405.
  • 37. Croisier-Bertin D., Piroth L., Charles P., et al. Ceftaroline versus ceftriaxone in a highly penicillin-resistant pneumococcal pneumonia rabbit model using simulated human dosing. Antimicrob Agents Chemother 2011; 55(7):3557-63.
  • 38. Rank D.R., Friedland H.D., Laudano J.B. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother 2011; 66(Suppl 3):iii53–iii59.
  • 39. Panagiotidis G., Bäckström T., Asker-Hagelberg C., Jandourek A., Weintraub A., Nord C.E. Effect of ceftaroline on normal human intestinal microflora. Antimicrob Agents Chemother 2010; 54(5):1811-4.
  • 40. Snydman D.R., Jacobus N.V., McDermott L.A. In vitro activity of ceftaroline against a broad spectrum of recent clinical anaerobic isolates. Antimicrob Agents Chemother 2011; 55(1):421-5.
  • 41. Corrado M.L. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65(Suppl 4):iv67– iv71.
  • 42. Mushtaq S., Warner M., Williams G. Activity of chequerboard combinations of ceftaroline and NXL104 versus β-lactamase-producing Enterobacteriaceae. J Antimicrob Chemother 2010; 65:1428-32.
  • 43. Wiskirchen D.E., Crandon J.L., Furtado G.H., et al. In vivo efficacy of a human-simulated regimen of ceftaroline combined with NXL104 against extended-spectrum-βlactamase (ESBL)-producing and non-ESBL-producing Enterobacteriaceae. Antimicrob Agents Chemother 2011; 55(7):3220-5.
  • 44. Castanheira M., Sader H.S., Farrell D.J., et al. Activity of ceftaroline-avibactam tested against Gram-negative organism populations, including strains expressing one or more β-lactamases and methicillin-resistant Staphylococcus aureus carrying various staphylococcal cassette chromosome mec types. Antimicrob Agents Chemother 2012; 56(9):4779-85.
  • 45. Louie A., Castanheira M., Liu W., et al. Pharmacodynamics of β-lactamase inhibition by NXL104 in combination with ceftaroline: examining organisms with multiple types of β-lactamases. Antimicrob Agents Chemother 2012; 56(1):258-70.
  • 46. Vidaillac C., Leonard S.N., Sader H.S., et al. In vitro activity of ceftaroline alone and in combination against clinical isolates of resistant Gram-negative pathogens, including β-lactamase-producing Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother 2009; 53(6):2360-6.
  • 47. Clark C., McGhee P., Appelbaum P.C., Kosowska-Shick K. Multistep resistance development studies of ceftaroline in Gram-positive and -negative bacteria. Antimicrob Agents Chemother 2011; 55(5):2344-51.
  • 48. Jacqueline C., Caillon J., Le Mabecque V., et al. In vivo efficacy of ceftaroline (PPI-0903), a new broad-spectrum cephalosporin, compared with linezolid and vancomycin against methicillin-resistant and vancomycin- intermediate Staphylococcus aureus in a rabbit endocarditis model. Antimicrob Agents Chemother 2007; 51(9):3397- 400.
  • 49. Jacqueline C., Amador G., Batard E., et al. Comparison of ceftaroline fosamil, daptomycin and tigecycline in an experimental rabbit endocarditis model caused by methicillin-susceptible, methicillin-resistant and glycopeptide-intermediate Staphylococcus aureus. J Antimicrob Chemother 2011; 66(4):863-6.
  • 50. Zhanel G.G., Rossnagel E., Nichol K., et al. Ceftaroline pharmacodynamic activity versus community-associated and healthcare-associated methicillin- resistant Staphylococcus aureus, heteroresistant vancomycinintermediate S. aureus, vancomycin-intermediate S. aureus and vancomycin-resistant S. aureus using an in vitro model. J Antimicrob Chemother 2011; 66(6):1301-5.
  • 51. Jacqueline C., Caillon J., Batard E., et al. Evaluation of the in vivo efficacy of intramuscularly administered ceftaroline fosamil, a novel cephalosporin, against a methicillin-resistant Staphylococcus aureus strain in a rabbit endocarditis model. J Antimicrob Chemother 2010; 65(10):2264-5.
  • 52. Jacqueline C., Caillon J., Le Mabecque V., et al. In vivo activity of a novel anti-methicillin-resistant Staphylococcus aureus cephalosporin, ceftaroline, against vancomycin-susceptible and -resistant Enterococcus faecalis strains in a rabbit endocarditis model: a comparative study with linezolid and vancomycin. Antimicrob Agents Chemother 2009; 53(12):5300-2.
  • 53. Jacqueline C., Amador G., Caillon J., et al. Efficacy of the new cephalosporin ceftaroline in the treatment of experimental methicillin-resistant Staphylococcus aureus acute osteomyelitis. J Antimicrob Chemother 2010; 65(8):1749-52.
  • 54. Cottagnoud P., Acosta F., Biek D., Cottagnoud M., Lieb S. Efficacy of ceftaroline fosamil against penicillinsensitive and –resistant Streptococcus pneumonia in an experimental rabbit meningitis model. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12–15, 2010; Boston, MA. Abstract B-702.
  • 55. Ge Y., Liao S., Thye D., et al. Ceftaroline (CPT) dose adjustment recommendations for subjects with mild or moderate renal impairment (RI). Abstracts of the Fortyseventh Interscience Conference on Antimicrobial Agents and Chemotherapy; 2007; Chicago, IL. Washington, DC, USA: American Society for Microbiology; Abstract A-35.
  • 56. Ge Y., Maynard D., Rickert D.E. Comparative pharmacokinetics of ceftaroline in rats, rabbits, and monkeys following a single intravenous or intramuscular injection. Antimicrob Agents Chemother 2010; 54(2):912-4.
  • 57. Riccobene T., Fang E., Thye D. A single- and multipledose study to determine the safety, tolerability, and pharmacokinetics (PK) of ceftaroline (CPT) administered by intramuscular (IM) injection to healthy subjects. Abstracts of the Forty-eighth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2008. Washington, DC, USA: American Society for Microbiology; Poster #A-1888
  • 58. Ge Y., Liao S., Thye D.A., Talbot G.H. Ceftaroline (CPT) dose adjustment recommendations for subjects with mild or moderate renal impairment (RI). 47th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17–20, 2007; Chicago, IL. Abstract A-35.
  • 59. Hernandez P.O., Lema S., Tyring S.K., et al. Ceftaroline in complicated skin and skin-structure infections. Infect Drug Resist 2012; 5:23–35.
  • 60. Labandeira-Rey M., Couzon F., Boisset S., et al. Staphylococcus aureus panton-valentine leukocidin causes necrotizing pneumonia. Science 2007; 315:1130-3.
Просмотров
0 Аннотация
0 PDF
0 Цитирования
Поделились