Optimal dosing regimen of biapenem in Chinese patients with lower respiratory tract infections based on population pharmacokinetic/pharmacodynamic modelling and Monte Carlo simulation

International Journal of Antimicrobial Agents

Volumn 47, Issue 3, 2016, Pages 202-209

  Dong, Jing ^a,b   Xiong, Wei ^c   Chen, Yuancheng ^d   Zhao, Yunfeng ^a   Lu, Yang ^e   Zhao, Di ^b   Li, Wenyan ^a   Liu, Yanhui ^a   Chen, Xijing ^b  

^a Shanghai Pudong New Area Gongli Hospital   (China)

^b CHINA PHARMACEUTICAL UNIVERSITY   (China)

^c TONGJI UNIVERSITY   (China)

^d FUDAN UNIVERSITY   (China)

^e University of North Carolina   (United States)

Author keywords

T>MIC; Biapenem; Lower respiratory tract infections; Monte Carlo simulation; Population pharmacokinetics

Indexed keywords

BIAPENEM; ANTIINFECTIVE AGENT; THIENAMYCIN DERIVATIVE;

ACINETOBACTER BAUMANNII; ADULT; AGED; ARTICLE; BACTERIAL STRAIN; BACTERIUM ISOLATE; CHINESE; CREATININE CLEARANCE; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG RESPONSE; ENTEROBACTER CLOACAE; ENTEROCOCCUS FAECIUM; ESCHERICHIA COLI; FEMALE; HUMAN; KLEBSIELLA PNEUMONIAE; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; MONTE CARLO METHOD; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSEUDOMONAS AERUGINOSA; VERY ELDERLY; BLOOD; CHINA; COMBINATION DRUG THERAPY; DRUG EFFECTS; ENTEROCOCCUS FAECALIS; ISOLATION AND PURIFICATION; MICROBIAL SENSITIVITY TEST; MICROBIOLOGY; RESPIRATORY TRACT INFECTIONS; STAPHYLOCOCCUS;

ACINETOBACTER BAUMANNII; ANTI-BACTERIAL AGENTS; CHINA; DRUG THERAPY, COMBINATION; ENTEROBACTER CLOACAE; ENTEROCOCCUS FAECALIS; ENTEROCOCCUS FAECIUM; ESCHERICHIA COLI; HUMANS; KLEBSIELLA PNEUMONIAE; MICROBIAL SENSITIVITY TESTS; MONTE CARLO METHOD; PROSPECTIVE STUDIES; PSEUDOMONAS AERUGINOSA; RESPIRATORY TRACT INFECTIONS; STAPHYLOCOCCUS; THIENAMYCINS;

EID: 84960213343     PISSN: 09248579     EISSN: 18727913     Source Type: Journal    
DOI: 10.1016/j.ijantimicag.2015.12.018     Document Type: Article

References (35)

1. M. Hikida, K. Kawashima, K. Nishiki, Y. Furukawa, K. Nishizawa, I. Saito, and et al. Renal dehydropeptidase-I stability of LJC 10,627, a new carbapenem antibiotic Antimicrob Agents Chemother 36 1992 481 483
2. Y. Yang, N. Bhachech, and K. Bush Biochemical comparison of imipenem, meropenem and biapenem: permeability, binding to penicillin-binding proteins, and stability to hydrolysis by β-lactamases J Antimicrob Chemother 35 1995 75 84
3. C.M. Perry, and T. Ibbotson Biapenem Drugs 62 2002 2221 2234
4. G.L. Drusano, S.L. Preston, C. Hardalo, R. Hare, C. Banfield, D. Andes, and et al. Use of preclinical data for selection of a phase II/III dose for evernimicin and identification of a preclinical MIC breakpoint Antimicrob Agents Chemother 45 2001 13 22
5. V.H. Tam, A. Louie, B.M. Lomaestro, and G.L. Drusano Integration of population pharmacokinetics, a pharmacodynamic target, and microbiologic surveillance data to generate a rational empiric dosing strategy for cefepime against Pseudomonas aeruginosa Pharmacotherapy 23 2003 291 295
6. Clinical and Laboratory Standards Institute Performance standards for antimicrobial susceptibility testing; twenty-third informational supplement. Document M100-S23 2014 CLSI Wayne, PA
7. K. Ikawa, N. Morikawa, K. Ikeda, H. Ohge, T. Sueda, H. Suyama, and et al. Pharmacokinetic-pharmacodynamic target attainment analysis of biapenem in adult patients: a dosing strategy Chemotherapy 54 2008 386 394
8. K. Ikawa, A. Nakashima, N. Morikawa, K. Ikeda, Y. Murakami, H. Ohge, and et al. Clinical pharmacokinetics of meropenem and biapenem in bile and dosing considerations for biliary tract infections based on site-specific pharmacodynamic target attainment Antimicrob Agents Chemother 55 2011 5609 5615
9. G.G. Zhanel, R. Wiebe, L. Dilay, K. Thomson, E. Rubinstein, D.J. Hoban, and et al. Comparative review of the carbapenems Drugs 67 2007 1027 1052
10. W.A. Craig Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men Clin Infect Dis 26 1998 1 10
11. G.L. Drusano Prevention of resistance: a goal for dose selection for antimicrobial agents Clin Infect Dis 36 2003 42 50
12. Y. Ohata, Y. Tomita, M. Nakayama, K. Tamura, and Y. Tanigawara Optimal treatment schedule of meropenem for adult patients with febrile neutropenia based on pharmacokinetic-pharmacodynamic analysis J Infect Chemother 17 2011 831 841
13. A. Ramon-Lopez, J.M. Allen, A.H. Thomson, B.S. Dheansa, S.E. James, G.W. Hanlon, and et al. Dosing regimen of meropenem for adults with severe burns: a population pharmacokinetic study with Monte Carlo simulations J Antimicrob Chemother 70 2015 882 890
14. D.W. Cockcroft, and H. Gault Prediction of creatinine clearance from serum creatinine Nephron 16 1976 1 41
15. Y. Liu, Z. Li, C. Yang, H. Zheng, Y. Lv, H. Chen, and et al. Tolerability and pharmacokinetics of biapenem following single and multiple intravenous administrations in healthy Chinese subjects: an open-label, randomized, single-center study Drug Res (Stuttg) 63 2013 396 403
16. Venables WN, Smith DM. R Development Core Team. R Version 2.1.4.0. The R Foundation for Statistical Computing. http://www.r-project.org [accessed May 2014].
17. U. Wählby, E.N. Jonsson, and M.O. Karlsson Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis AAPS PharmSci 4 2002 E27
18. M. Bergstrand, A.C. Hooker, J.E. Wallin, and M.O. Karlsson Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models AAPS J 13 2011 143 151
19. J.W. Mouton, M.N. Dudley, O. Cars, H. Derendorf, and G.L. Drusano Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs: an update J Antimicrob Chemother 55 2005 601 607
20. C.A. DeRyke, J.L. Kuti, and D.P. Nicolau Reevaluation of current susceptibility breakpoints for Gram-negative rods based on pharmacodynamic assessment Diagn Microbiol Infect Dis 58 2007 337 344
21. P. Kiratisin, R.A. Keel, and D.P. Nicolau Pharmacodynamic profiling of doripenem, imipenem and meropenem against prevalent Gram-negative organisms in the Asia-Pacific region Int J Antimicrob Agents 41 2013 47 51
22. J.A. Roberts, A. Kwa, P. Montakantikul, C. Gomersall, J.L. Kuti, and D.P. Nicolau Pharmacodynamic profiling of intravenous antibiotics against prevalent Gram-negative organisms across the globe: the PASSPORT Program - Asia-Pacific Region Int J Antimicrob Agents 37 2011 225 229
23. K. Ikawa, N. Morikawa, K. Ikeda, M. Miki, S. Nishimura, and M. Kobayashi Population pharmacokinetics and pharmacodynamics of biapenem in paediatric patients J Clin Pharm Ther 33 2008 203 210
24. M. Nakashima, T. Uematsu, K. Ueno, S. Nagashima, H. Inaba, M. Nakano, and et al. Phase 1 study of L-627, biapenem, a new parenteral carbapenem antibiotic Int J Clin Pharmacol Ther Toxicol 31 1993 70 76
25. T. Niwa, A. Nakamura, T. Kato, T. Kutsuna, K. Katou, H. Morita, and et al. Pharmacokinetic study of pleural fluid penetration of carbapenem antibiotic agents in chemical pleurisy Respir Med 100 2006 324 331
26. F. Tarao, T. Miura, A. Saito, and K. Sato Pharmacokinetic study of biapenem Jpn J Chemother 44 1996 769 775
27. K. Ikawa, N. Morikawa, K. Ikeda, H. Ohge, and T. Sueda Pharmacodynamic evaluation of biapenem in peritoneal fluid using population pharmacokinetic modelling and Monte Carlo simulation Int J Antimicrob Agents 32 2008 339 343
28. L. Zhao, Y. Liu, Z. Kou, A. Bayasi, H. Cai, C. Zhang, and et al. Improved RP-HPLC method to determine biapenem in human plasma/urine and its application to a pharmacokinetic study Arzneimittelforschung 61 2011 197 204
29. R.E. Ariano, A. Nyhlén, J.P. Donnelly, D.S. Sitar, G.K. Harding, and S.A. Zelenitsky Pharmacokinetics and pharmacodynamics of meropenem in febrile neutropenic patients with bacteremia Ann Pharmacother 39 2005 32 38
30. Q.T. Zhou, B. He, C. Zhang, S.D. Zhai, Z.Y. Liu, and J. Zhang Pharmacokinetics and pharmacodynamics of meropenem in elderly Chinese with lower respiratory tract infections: population pharmacokinetics analysis using nonlinear mixed-effects modelling and clinical pharmacodynamics study Drugs Aging 28 2011 903 912
31. P.S. McKinnon, J.A. Paladino, and J.J. Schentag Evaluation of area under the inhibitory curve (AUIC) and time above the minimum inhibitory concentration (T > MIC) as predictors of outcome for cefepime and ceftazidime in serious bacterial infections Int J Antimicrob Agents 31 2008 345 351
32. E. Kikuchi, J. Kikuchi, Y. Nasuhara, S. Oizumi, A. Ishizaka, and M. Nishimura Comparison of the pharmacodynamics of biapenem in bronchial epithelial lining fluid in healthy volunteers given half-hour and three-hour intravenous infusions Antimicrob Agents Chemother 53 2009 2799 2803
33. M. Xia, T.J. Hang, F. Zhang, X.M. Li, and X.Y. Xu The stability of biapenem and structural identification of impurities in aqueous solution J Pharm Biomed Anal 49 2009 937 944
34. X. Ma, J. Cui, J. Wang, Y. Chang, Q. Fang, C. Bai, and et al. Multicentre investigation of pathogenic bacteria and antibiotic resistance genes in Chinese patients with acute exacerbation of chronic obstructive pulmonary disease J Int Med Res 43 2015 699 710
35. F. Karino, K. Miura, H. Fuchita, N. Koba, E. Nishikawa, T. Hotta, and et al. Efficacy and safety of piperacillin/tazobactam versus biapenem in late elderly patients with nursing- and healthcare-associated pneumonia J Infect Chemother 19 2013 909 915