Main Article Content

Abstract

A growing problem in the medical field is the development of antibiotic resistant pathogens. One reason this development is so important is that in recent years there is a shortage of new antibiotics in development to combat resistant pathogens. It worths to mention that while 19 new antibiotics were released in the period 1980 to 1984, this had dropped to just three in the period 2005 to 2009. Ironically, the shortage of new antibiotics occur in the era where growing number of pathogens develop resistance to multiple antibiotics that previously effectively used to treat the infections. As a consequent, it is essential that the efficacy of last resort antibiotics, including the new antibiotics, be maintained as long as possible. Ceftaroline is a new antibiotic in Indonesia market which has methicillin-resistant Staphylococcus aureus activity and it belongs to the cephalosporins. Further understanding related to basic profile of ceftaroline, efficacy and safety, cost, and place in therapy is needed to optimize the responsible used of ceftaroline in daily medical practice

Keywords

Ceftaroline, Cephalosporins, Methicillin-resistant Staphylococcus aureus

Article Details

How to Cite
Halim, S. V., & Setiawan, E. (2020). Seftarolin, Antibiotik Baru dengan Aktivitas Anti-MRSA: Sebuah Kajian Efektivitas, Keamanan, dan Biaya Penggunaan : Ceftaroline, a New Anti-MRSA Antibiotic: a Review of the Efficacy, Safety, and Cost of Utilisation. Jurnal Farmasi Galenika (Galenika Journal of Pharmacy) (e-Journal), 6(1), 160 - 180. https://doi.org/10.22487/j24428744.2020.v6.i1.15015

References

  1. American society of health-system pharmacist. (2018). AHFS drug information. Canada: American Society of Health-System Pharmacists, Inc.
  2. Beauduy, C., & Winston, L. (2018). Beta-lactam & other cell wall & membrane-active antibiotics. In B. Katzung (Ed.), Basic & Clinical Pharmacology (14th ed, pp. 795–814). North America: McGraw-Hill Companies, Inc.
  3. Bhavnani, S., Hammel, J., Van Wart, S., Rubino, C., Reynolds, D., Forrest, A., … Friedland, H. (2013). Pharmacokinetic-pharmacodynamic analyses for efficacy of ceftaroline fosamil in patients with community-acquired bacterial pneumonia. Antimicrob Agents Chemother, 57(12), 6348–6350.
  4. Cano, E., Haque, N., Welch, V., Cely, C., Peyrani, P., Scerpella, E., … Zervos, M. (2012). Incidence of nephrotoxicity and association with vancomycin use in intensive care unit patients with pneumonia: retrospective analysis of the IMPACT-HAP database. Clin Ther, 34(1), 149–157.
  5. Canut, A., Isla, A., Betriu, C., & Gascón, A. (2012). Pharmacokinetic-pharmacodynamic evaluation of daptomycin, tigecycline, and linezolid versus vancomycin for the treatment of MRSA infections in four western European countries. Eur J Clin Microbiol Infect Dis, 3(9), 2227–2235.
  6. Centers for Disease Control. (2013). Centers for Disease Control and Prevention, Office of Infectious Disease Antibiotic resistance threats in the United States. Retrieved November 28, 2019, from http://www.cdc.gov/drugresistance/ threat-report-2013
  7. Chen, Chih-wei, Chang, S., Huang, H., Tang, H., & Lai, C. (2019). The efficacy and safety of ceftaroline in the treatment of acute bacterial infection in pediatric patients – a systemic review and meta-analysis of randomized controlled trials. Infection and Drug Resistance, 12, 1303–1310.
  8. Chen, CJ, & Huang, Y. (2014). New epidemiology of Staphylococcus aureus in Asia. Clin Microbiol Infect, 20(7), 605–623.
  9. Chou, C., Shen, C., Chen, S., Chen, H., Wang, Y., Chang, W., … Chen, W. (2019). Recommendations and guidelines for the treatment of pneumonia in Taiwan. Journal of Microbiology, Immunology and Infection, 52, 172–199.
  10. Craig, W., & Andes, D. (2015). Cephalosporins. In J. Bennett, R. Dolin, & M. Blaser (Eds.), Principles and practice of infectious diseases (8th ed, pp. 278–292). Canada: Elsevier Inc.
  11. Das, S., Li, J., Iaconis, J., Zhou, D., Stone, G., Yan, J., & Melnick, D. (2019). Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother, 74(2), 425–431.
  12. Devleesschauwer, B., de Noordhout, C., Smit, G., Duchateau, L., Dorny, P., Stein, C., … Speybroeck, N. (2014). Quantifying burden of disease to support public health policy in Belgium: opportunities and constraints. BMC Public Health, 14(1196), 1–8.
  13. Ding, J., Sun, Q., Li, K., Zheng, M., Miao, X., Ni, W., … Yang, J. (2009). Retrospective analysis of nosocomial infections in the intensive care unit of a tertiary hospital in China during 2003 and 2007. BMC Infect Dis, 9(115).
  14. Dong, Y., Chbat, N., Gupta, A., Hadzikadic, M., & Gajic, O. (2012). Systems modelling and simulation applications for critical care medicine. Ann Intensive Care, 2(1), 18.
  15. Doyle, J., Buising, K., Thursky, K., Worth, L., & Richards, M. (2011). Epidemiology of infections acquired in intensive care units. Semin Respir Crit Care Med, 32(2), 115–138.
  16. European Committee on Antimicrobial Susceptibility Testing. (n.d.). Antimicrobial wild type distributions of microorganisms. Retrieved November 20, 2019, from http://mic.eucast.org/Eucast2/SearchController/search.jsp?action=performSearch&BeginIndex=0&Micdif=mic&NumberIndex=50&Antib=38&Specium=-1
  17. European Medicines Agency. (2019). Zinforo: summary of product characteristic. Retrieved November 10, 2019, from https://www.ema.europa.eu/en/documents/product-information/zinforo-epar-product-information_en.pdf
  18. Food and Drug Administration. (2012). Teflaro (ceftaroline fosamil) injection. Retrieved November 10, 2019, from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327orig1s000toc.cfm
  19. Gallagher, J., & MacDougall, C. (2018). Antibiotics simplified (4th ed). Philadelphia: Jones & Bartlett Learning.
  20. GBD 2015 and HALE Collborators. (2016). Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet, 388, 1603–1658.
  21. Golan, Y. (2019). Current Treatment Options for Acute Skin and Skin- structure Infections. Clinical Infectious Diseases, 68(S3), S206-12.
  22. Hajj, M., Turgeon, R., & Wilby, K. (2017). Ceftaroline fosamil for community-acquired pneumonia and skin and skin structure infections : a systematic review. International Journal of Clinical Pharmacy.
  23. Jorgensen, J., & Ferraro, M. (2009). Antimicrobial susceptibility testing: a review of general principles and contemporary practices. Clinical Infectious Diseases, 49, 1749–1755.
  24. Kmietowicz, Z. (2017). Few novel antibiotics in the pipeline, WHO warns. BMJ, 358(j4339).
  25. Kullar, R., Davis, S., Levine, D., & Rybak, M. (2011). Impact of vancomycin exposure on outcomes in patients with methicillin-resistant Staphylococcus aureus bacteremia: support for consensus guidelines suggested targets. Clin Infect Dis, 52(8), 975–981.
  26. Kuti, K. (2016). Optimizing antimicrobial pharmacodynamics: a guide for your stewardship program. Rev Med Clin Condes, 27(5), 615–624.
  27. Lan, S., Chang, S., Lai, C., & Lu, L. (2019). Ceftaroline Efficacy and Safety in Treatment of Complicated Skin and Soft Tissue Infection : A Systemic Review and Meta-Analysis of Randomized Controlled Trials. Journal of Clinical Medicine, 8(776), 1–10.
  28. Lan, S., Chang, S., Lai, C., Lu, L., & Chao, C. (2019). Efficacy and Safety of Ceftaroline for the Treatment of Community-Acquired Pneumonia : A Systemic Review and Meta-Analysis of Randomized Controlled Trials. Journal of Clinical Medicine, 8(824).
  29. Li, J., Das, S., Zhou, D., & Al-Huniti, N. (2019). Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With Ceftaroline Fosamil. Clin Pharmacol Drug Dev, 8(5), 682–694.
  30. Liu, C., Bayer, A., Cosgrove, S., Daum, R., Fridkin, S., Gowritz, R., … Karchmer, A. (2011). 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(3), 18–55.
  31. Lobanovska, M., & Pilla, G. (2017). Penicillin’s discovery and antibiotic resistance: lessons for the future? Yale J Biol Med, 90(1), 135–145.
  32. Metlay, J. P., Waterer, G. W., Long, A. C., Anzueto, A., Brozek, J., Crothers, K., … Musher, D. M. (2019). Diagnosis and Treatment of Adults with Community-acquired Pneumonia: an Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. American Thoracic Society, 200(7). https://doi.org/10.1164/rccm.201908-1581ST
  33. Minejima, E., Choi, J., Beringer, P., Lou, M., Tse, E., & Wong-Beringer, A. (2011). Applying new diagnostic criteria for acute kidney injury to facilitate early identification of nephrotoxicity in vancomycin-treated patients. Antimicrob Agents Chemother, 55(7), 3278–3283.
  34. Moore, C., Osaki-Kiyan, P., Haque, N., Perri, M., Donabedian, S., & Zervos, M. (2011). Daptomycin versus vancomycin for bloodstream infections due to methicillin-resistant Staphylococcus aureus with a high vancomycin minimum inhibitory concentration: a case-control study. Clin Infect Dis, 54(1), 51–58.
  35. National Institute for Health and Care Excellence. (2019). Pneumonia (community-acquired): antimicrobial prescribing. NICE Guideline, 1–30.
  36. O’Neill, J. (2014). Antimicrobial resistance: tackling a crisis for the health and wealth of nations. 2014. Retrieved November 20, 2019, from https://amr-review.org/sites/default/files/ AMR%2520Review%25 20Paper%2520-%2520Tackling%2520a%2520crisis%2520for %2520the%2520health%2520and%2520wealth%2520of%2520nations_1.pdf
  37. Onufrak, N., Forrest, A., & Gonzalez, D. (2016). Pharmacokinetic and pharmacodynamic principles of anti-infective dosing. Clin Ther, 38(9), 1930–1947.
  38. Pitz, A., Yu, F., Hermsen, E., Rupp, M., Fey, P., & Olsen, K. (2011). Vancomycin susceptibility trends and prevalence of heterogeneous vancomycin-intermediate Staphylococcus aureus in clinical methicillin-resistant S. aureus isolates. J Clin Microbiol, 49(1), 269–274.
  39. Pritchard, L., Baker, C., Leggett, J., Sehdev, P., Brown, A., & Bayley, K. (2010). Increasing vancomycin serum trough concentrations and incidence of nephrotoxicity. Am J Med, 123(12), 1143–1149.
  40. Roberts, J., Abdul-Aziz, Lipman, J., Mouton, J., Vinks, A., Felton, T., … Farkas, A. (2014). Individualised antibiotic dosing for patients who are critically ill: challenges and potential solutionso Title. Lancet Infect Dis, 14, 498–509.
  41. Roberts, J., Kirkpatrick, C., & Lipman, J. (2011). Monte Carlo simulations: maximizing antibiotic pharmacokinetic data to optimize clinical practice for critically ill patients. J Antimicrob Chemother, 66(2), 227–231.
  42. Rowland, M., & Tozer, T. (2011). Clinical pharmacokinetics and pharmacodynamics: concepts and applications (4th ed). China: Lippincott Williams & Wilkins.
  43. Santoso, A., Pusponegoro, A., Sani, A., Rani, A., Lelo, A., Kartasasmita, C., … Harimurti, G. (2018). MIMS referensi obat: informasi ringkas produk obat. Jakarta: PT. Bhuana Ilmu Populer (Kelompok Gramedia).
  44. Sauermann, R., Rothenburger, M., Graninger, W., & Joukhadar, C. (2008). Daptomycin: a review 4 years after first approval. Pharmacology, 81(2), 79–91.
  45. Setiawan, E., & Montakantikul, P. (2018). Pharmacokinetic and Pharmacodynamic Approach in Adult Critically-Ill Patients Treated with Standard Dose of Vancomycin for MRSA Infection. Journal of Medical Association of Thailand, 101(5), 555–562.
  46. Setiawan, E., Suwannoi, L., Montakantikul, P., & Chindavijak, B. (2019). Optimization of Intermittent Vancomycin Dosage Regimens for Thai Critically Ill Population Infected by MRSA in the Era of “MIC Creep” Phenomenon. Acta Medica Indonesiana - Indones J Intern Med, 51(1), 10–18.
  47. Setiawan, E., Widyati, W., Marpaung, F., Sukandar, E., Susaniwati, S., Lukas, D., & Wiyono, H. (2019). Narrative Review on Pharmacokinetics of Antibiotics among Critically Ill Patients: the Implication on the Pharmacokinetics-Pharmacodynamics Target Attainment. Pharmaceutical Sciences and Research, 6(1), 1–12.
  48. Silverman, J., Mortin, L., Vanpraagh, A., Li, T., & Alder, J. (2005). Inhibition of daptomycin by pulmonary surfactant: in vitro modeling and clinical impact. J Infect Dis, 191(12), 2149–2152.
  49. Sotgiu, G., Aliberti, S., Gramegna, A., Mantero, M., Pasquale, M. Di, Trogu, F., … Blasi, F. (2018). Efficacy and effectiveness of Ceftaroline Fosamil in patients with pneumonia: a systematic review and meta-analysis. Respiratory Research, 19(205), 1–13.
  50. Spapen, H., Jansen van Doorn, K., Diltoer, M., Verbrugghe, W., Jacobs, R., Dobbeleir, N., … Jorens, P. (2011). Retrospective evaluation of possible renal toxicity associated with continuous infusion of vancomycin in critically ill patients. Ann Intensive Care, 1(1), 26.
  51. Stevens, D. L., Bisno, A. L., Chambers, H. F., Dellinger, E. P., Goldstein, E. J. C., Gorbach, S. L., … Wade, J. C. (2014). Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections: 2014 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases, 99, 147–159.
  52. Therapeutic Goods Administration Health Safety Regulation. (2013). Australian public assessment report for ceftaroline fosamil. Australia.
  53. Tortora, G., Funke, B., & Case, C. (2019). Antimicrobial drugs. In Microbiology: an introduction (13th ed, pp. 558–574). United State: Pearson Education, Inc.
  54. Traebert, J., Nickel, D., Traebert, E., Escalante, J., & Schneider, I. (2016). The burden of infectious diseases in the Brazilian Southern state of Santa Catarina. J Infect Public Health, 9(2), 181–191.
  55. Tsering, D., Pal, R., & Kar, S. (2011). Methicillin-Resistant Staphylococcus Aureus: prevalence and current susceptibility pattern in Sikkim. J Glob Infect Dis, 3(1), 9–13.
  56. van Hal, S., Lodise, T., & Paterson, D. (2012). The clinical significance of vancomycin minimum inhibitory concentration in Staphylococcus aureus infections: a systematic review and meta-analysis. Clin Infect Dis, 54(6), 755–771.
  57. Van Lier, A., McDonald, S., Bouwknegt, M., Kretzscmar, M., Havelaar, A., Mangen, M., & Wallinga, J. (2016). Disease burden of 32 infectious diseases in the Netherlands, 2007-2011. PLoS One, 11(4).
  58. Vincent, J., Rello, J., Marshall, J., Silva, E., Anzueto, A., Martin, C., … Lipman, J. (2009). International study of the prevalence and outcomes of infection in intensive care units. JAMA, 302(21), 2323–2329.
  59. Wi, Y., Kim, J., Joo, E., Ha, Y., Kang, C., & Ko, K. (2012). High vancomycin minimum inhibitory concentration is a predictor of mortality in methicillin-resistant Staphylococcus aureus bacteraemia. Int J Antimicrob Agents, 40(2), 108–113.
  60. Wong-Beringer, A., Joo, J., Tse, E., & Beringer, P. (2011). Vancomycin-associated nephrotoxicity: a critical appraisal of risk with high-dose therapy. Int J Antimicrob Agents, 37(2), 95–101.
  61. World Health Organization. (2019). The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Retrieved November 10, 2019, from https://www.who.int/medicines/news/2019/WHO_releases2019AWaRe_classification_antibiotics/en/
  62. Yeh, Y., Yeh, K., Lin, T., Chiu, S., Yang, Y., Wang, Y., & Lin, J. (2012). Impact of vancomycin MIC creep on patients with methicillin-resistant Staphylococcus aureus bacteremia. J Microbiol Immunol Infect, 45(3), 214–220.
  63. Zhanel, G. G., Sniezek, G., Schweizer, F., Zelenitsky, S., Rubinstein, E., Gin, A. S., … Karlowsky, J. A. (2009). Ceftaroline: a novel broad-spectrum cephalosporin with activity against methicillin-resistant Stapylococcus aureus. Drugs, 69(7), 809–831.