Pharmacokinetic/pharmacodynamic modeling and simulation of cefiderocol, a parenteral siderophore cephalosporin, for dose adjustment based on renal function

Antimicrobial Agents and Chemotherapy

Volumn 61, Issue 1, 2017, Pages

  Katsube, Takayuki ^a   Wajima, Toshihiro ^a   Ishibashi, Toru ^a   Arjona Ferreira, Juan Camilo ^a   Echols, Roger ^a  

^a SHIONOGI AND CO LTD   (Japan)

Author keywords

Cefiderocol; Cephalosporin; Dose adjustment; Hemodialysis; Modeling and simulation; Pharmacodynamics; Pharmacokinetics; Population pharmacokinetics; Renal function

Indexed keywords

CEFIDEROCOL; CREATININE; SIDEROPHORE; ANTIINFECTIVE AGENT; CEPHALOSPORIN DERIVATIVE;

ADULT; ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DIALYSATE LEVEL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EXPOSURE; DRUG URINE LEVEL; ESTIMATED GLOMERULAR FILTRATION RATE; FEMALE; HEMODIALYSIS; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MINIMUM INHIBITORY CONCENTRATION; MONTE CARLO METHOD; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROCESS MODEL; SIMULATION; CLINICAL TRIAL; KIDNEY; METABOLISM; MICROBIAL SENSITIVITY TEST; MIDDLE AGED;

ANTI-BACTERIAL AGENTS; CEPHALOSPORINS; HUMANS; KIDNEY; MALE; MICROBIAL SENSITIVITY TESTS; MIDDLE AGED; MONTE CARLO METHOD; RENAL DIALYSIS; SIDEROPHORES;

EID: 85009274824     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01381-16     Document Type: Article

References (27)

1. Ito A, Kohira N, Bouchillon SK, West J, Rittenhouse S, Sader HS, Rhomberg PR, Jones RN, Yoshizawa H, Nakamura R, Tsuji M, Yamano Y. 2016. In vitro antimicrobial activity of S-649266, a catechol substituted siderophore cephalosporin, when tested against non-fermenting gram-negative bacteria. J Antimicrob Chemother 71:1-12. https://doi.org/10.1093/jac/dkv402.
2. Kohira N, West J, Ito A, Ito-Horiyama T, Nakamura R, Sato T, Rittenhouse S, Tsuji M, Yamano Y. 2015. In vitro antimicrobial activity of a siderophore cephalosporin, S-649266, against Enterobacteriaceae clinical isolates, including carbapenem-resistant strains. Antimicrob Agents Chemother 60:729-734. https://doi.org/10.1128/AAC.01695-15.
3. Ito A, Toba S, Nishikawa T, Oota M, Kanazawa S, Fukuhara N, Yamaguchi T, Nakamura R, Tsuji M, Yamano Y. 2015. S-649266, a novel siderophore cephalosporin: binding affinity to PBP and in vitro bactericidal activity, abstr ECCMID-1871. Abstr 25th Eur Cong Clin Microbiol Infect Dis.
4. Nakamura R, Toba S, Tsuji M, Yamano Y, Shimada J. 2014. A novel siderophore cephalosporin. IV. In vivo efficacy in various murine infection models, abstr F-1558. Abstr 54th Intersci Conf Antimicrob Agents Chemother.
5. Nakamura R, Toba S, Ito A, Tsuji M, Yamano Y, Shimada J. 2014. A novel siderophore cephalosporin. V. Pharmacodynamic assessment in murine thigh infection models, abstr F-1559. Abstr 54th Intersci Conf Antimicrob Agents Chemother.
6. Horiyama T, Toba S, Nakamura R, Tsuji M, Yamano Y, Shimada J. 2014. A novel siderophore cephalosporin. VI. Magnitude of PK/PD parameter required for efficacy in murine lung infection model, abstr F-1560. Abstr 54th Intersci Conf Antimicrob Agents Chemother.
7. Horiyama T, Toba S, Nakamura R, Tsuji M, Yamano Y, Shimada J. 2014. A novel siderophore cephalosporin. VII. Magnitude of PK/PD parameter required for efficacy in murine thigh infection model, abstr F-1561. Abstr 54th Intersci Conf Antimicrob Agents Chemother.
8. Craig WA. 1995. Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broad-spectrum cephalosporins. Diagn Microbiol Infect Dis 22:89-96. https://doi.org/10.1016/0732-8893(95)00053-D.
9. Craig WA. 1998. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 26:1-12. https://doi.org/10.1086/516284.
10. Shimada J, Saisho Y, Katsube T, White S, Fukase H. 2014. S-649266, a novel siderophore cephalosporin for gram negative bacterial infections: pharmacokinetics, safety and tolerability in healthy subjects, abstr F-1564. Abstr 54th Intersci Conf Antimicrob Agents Chemother.
11. Echols R, Katsube T, Arjona Ferreira JC, Krenz HK. 2015. S-649266, a siderophore cephalosporin for gram negative bacterial infection: pharmacokinetics and safety in subjects with renal impairment, abstr ECCMD-1174. Abstr 25th Eur Cong Clin Microbiol Infect Dis.
12. Roberts JA, Abdul-Aziz MH, Lipman J, Mouton JW, Vinks AA, Felton TW, Hope WW, Farkas A, Neely MN, Schentag JJ, Drusano G, Frey OR, Theuretzbacher U, Kuti JL, International Society of Anti-Infective Pharmacology and the Pharmacokinetics and Pharmacodynamics Study Group of the European Society of Clinical Microbiology and Infectious Diseases. 2014. Individualised antibiotic dosing for patients who are critically ill: challenges and potential solutions. Lancet Infect Dis 14:498-509. https://doi.org/10.1016/S1473-3099(14)70036-2.
13. Nandy P, Samtani MN, Lin R. 2010. Population pharmacokinetics of doripenem based on data from phase 1 studies with healthy volunteers and phase 2 and 3 studies with critically ill patients. Antimicrob Agents Chemother 54:2354-2359. https://doi.org/10.1128/AAC.01649-09.
14. Georges B, Conil JM, Seguin T, Dieye E, Cougot P, Decun JF, Lavit M, Samii K, Houin G, Saivin S. 2008. Cefepime in intensive care unit patients: validation of a population pharmacokinetic approach and influence of covariables. Int J Clin Pharmacol Ther 46:157-164. https://doi.org/10.5414/CPP46157.
15. Georges B, Conil JM, Seguin T, Ruiz S, Minville V, Cougot P, Decun JF, Gonzalez H, Houin G, Fourcade O, Saivin S. 2009. Population pharmacokinetics of ceftazidime in intensive care unit patients: influence of glomerular filtration rate, mechanical ventilation, and reason for admission. Antimicrob Agents Chemother 53:4483-4489. https://doi.org/10.1128/AAC.00430-09.
16. Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F, Chronic Kidney Disease Epidemiology Collaboration. 2006. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 145:247-254. https://doi.org/10.7326/0003-4819-145-4-200608150-00004.
17. Lin J, Knight EL, Hogan ML, Singh AK. 2003. A comparison of prediction equations for estimating glomerular filtration rate in adults without kidney disease. J Am Soc Nephrol 14:2573-2580. https://doi.org/10.1097/01.ASN.0000088721.98173.4B.
18. Stevens LA, Nolin TD, Richardson MM, Feldman HI, Lewis JB, Rodby R, Townsend R, Okparavero A, Zhang YL, Schmid CH, Levey AS, Chronic Kidney Disease Epidemiology Collaboration. 2009. Comparison of drug dosing recommendations based on measured GFR and kidney function estimating equations. Am J Kidney Dis 54:33-42. https://doi.org/10.1053/j.ajkd.2009.03.008.
19. Baptista JP, Udy AA, Sousa E, Pimentel J, Wang L, Roberts JA, Lipman J. 2011. A comparison of estimates of glomerular filtration in critically ill patients with augmented renal clearance. Crit Care 15:R139. https://doi.org/10.1186/cc10262.
20. Mosteller RD. 1987. Simplified calculation of body-surface area. N Engl J Med 317:1098.
21. U.S. FDA. Teflaro (ceftaroline fosamil) for injection: US prescribing information. FDA, Washington, DC.
22. U.S. FDA. Zerbaxa (ceftolozane/tazobactam) for injection: US prescribing information. FDA, Washington, DC.
23. Cockcroft DW, Gault MH. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41. https://doi.org/10.1159/000180580.
24. Holford NH. 2005. The visual predictive check-superiority to standard diagnostic (Rorschach) plots, abstr 738. PAGE 14. www.pagemeeting.org/?abstr=738.
25. Beal SL, Sheiner LB, Boeckmann AJ. 1989-2006. NONMEM users guide. Icon Development Solutions, Ellicott City, MD.
26. Lindbom L, Pihlgren P, Jonsson EN. 2005. PsN-Toolkit - a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput Methods Programs Biomed 79:241-257. https://doi.org/10.1016/j.cmpb.2005.04.005.
27. R Core Team. 2013. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.