Comparable population pharmacokinetics and pharmacodynamic breakpoints of cefpirome in cystic fibrosis patients and healthy volunteers

Antimicrobial Agents and Chemotherapy

Volumn 55, Issue 6, 2011, Pages 2927-2936

  Bulitta, J B ^a,b   Kinzig, M ^a   Landersdorfer, C B ^a,b   Holzgrabe, U ^c   Stephan, U ^a,d   Sorgel F ^a,d  

^a Institute for Biomedical and Pharmaceutical Research   (Germany)

^b ORDWAY RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF WÜRZBURG   (Germany)

^d UNIVERSITY OF DUISBURG ESSEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CEFPIROME;

ADULT; ARTICLE; BODY SIZE; CLINICAL ARTICLE; CONTROLLED STUDY; CYSTIC FIBROSIS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG URINE LEVEL; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; KIDNEY CLEARANCE; LEAN BODY WEIGHT; MALE; MINIMUM INHIBITORY CONCENTRATION; MONTE CARLO METHOD; PRIORITY JOURNAL; SINGLE DRUG DOSE;

ADOLESCENT; ADULT; ANTI-BACTERIAL AGENTS; BODY SIZE; CEPHALOSPORINS; CYSTIC FIBROSIS; FEMALE; HUMANS; MALE; MICROBIAL SENSITIVITY TESTS; MONTE CARLO METHOD;

EID: 79956298400     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01484-10     Document Type: Article

References (67)

1. Abe, N., et al. 2005. In vitro activity of antimicrobial agents against clinical isolates of Pseudomonas aeruginosa. Jpn. J. Antibiot. 58:445-451. (In Japanese.)
2. Anderson, B. J., and N. H. Holford. 2008. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu. Rev. Pharmacol. Toxicol. 48:303-332.
3. Badian, M., et al. 1988. Safety, tolerance and pharmacokinetics of 2.0 g cefpirome (HR 810) after single and multiple dosing. Chemotherapy 34:367-373.
4. Baltch, A. L., R. P. Smith, and W. Ritz. 1994. Comparative antimicrobial activity of FK037, cefpirome, ceftazidime and cefepime against aminoglycoside-sensitive and aminoglycoside-resistant Pseudomonas aeruginosa and Pseudomonas spp. Chemotherapy 40:391-398. (Pubitemid 24319023)
5. Barnaud, G., et al. 2001. Extension of resistance to cefepime and cefpirome associated to a six amino acid deletion in the H-10 helix of the cephalosporinase of an Enterobacter cloacae clinical isolate. FEMS Microbiol. Lett. 195:185-190.
6. Bauer, R. J. 2010. S-ADAPT/MCPEM user's guide (version 1.57). Software for Pharmacokinetic, Pharmacodynamic and Population Data Analysis, Berkeley, CA.
7. Beal, S. L. 2001. Ways to fit a PK model with some data below the quantification limit. J. Pharmacokinet. Pharmacodyn. 28:481-504.
8. Beal, S. L., L. B. Sheiner, and A. J. Boeckmann. 2006. NONMEM users guides (1989-2006). Icon Development Solutions, Ellicott City, MD.
9. Bell, J. M., and J. D. Turnidge. 2001. Multicentre study of the in vitro activity of cefepime, a broad-spectrum cephalosporin, compared to other broadspectrum agents. Pathology 33:53-60.
10. Boucher, H. W., et al. 2009. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin. Infect. Dis. 48:1-12.
11. Brendel, K., E. Comets, C. Laffont, C. Laveille, and F. Mentre. 2006. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm. Res. 23:2036-2049.
12. British Society for Antimicrobial Chemotherapy. 2010. BSAC methods for antimicrobial susceptibility testing, version 9.1, March 2010. British Society for Antimicrobial Chemotherapy, Birmingham, United Kingdom. http://www.bsac.org. uk/OneStopCMS/Core/CrawlerResourceServer.aspx?resource= 91e90e413e0c4749bf7ea21ad8953db5&mode=link&guid= 05fa35521c894d7ca6a31eb49a56bdd9.
13. Bulitta, J., et al. 2005. Cystic fibrosis patients are pharmacokinetically comparable to healthy volunteers, abstr. 1923 (p. A-12). Abstr. 45th Intersci. Conf. Antimicrob. Agents Chemother. ASM Press, Washington, DC.
14. Bulitta, J. B., A. Bingolbali, B. S. Shin, and C. B. Landersdorfer. 3 March 2011, posting date. Development of a new pre- and post-processing tool (SADAPT-TRAN) for nonlinear mixed-effects modeling in S-ADAPT. AAPS J. doi:10.1208/s12248-011-9257-x.
15. Bulitta, J. B., et al. 2006. Pharmacodynamic comparison of cystic fibrosis patients and healthy volunteers by population pharmacokinetics (PK) and Monte Carlo simulation, poster W4056. Presented at the 2006 AAPS Annu. Meet., San Antonio, TX, 29 October to 2 November, 2006.
16. Bulitta, J. B., et al. 2007. Systematic comparison of the population pharmacokinetics and pharmacodynamics of piperacillin in cystic fibrosis patients and healthy volunteers. Antimicrob. Agents Chemother. 51:2497-2507.
17. Bulitta, J. B., et al. 2009. Comparison of the pharmacokinetics and pharmacodynamic profile of carumonam in cystic fibrosis patients and healthy volunteers. Diagn. Microbiol. Infect. Dis. 65:130-141.
18. Bulitta, J. B., et al. 2010. Population pharmacokinetic comparison and pharmacodynamic breakpoints of ceftazidime in cystic fibrosis patients and healthy volunteers. Antimicrob. Agents Chemother. 54:1275-1282.
19. Bulitta, J. B., C. B. Landersdorfer, M. Kinzig, U. Holzgrabe, and F. Sorgel. 2009. New semiphysiological absorption model to assess the pharmacodynamic profile of cefuroxime axetil using nonparametric and parametric population pharmacokinetics. Antimicrob. Agents Chemother. 53:3462-3471.
20. Cavallo, J. D., R. Fabre, F. Leblanc, M. H. Nicolas-Chanoine, and A. Thabaut. 2000. Antibiotic susceptibility and mechanisms of beta-lactam resistance in 1,310 strains of Pseudomonas aeruginosa: a French multicentre study (1996). J. Antimicrob. Chemother. 46:133-136.
21. Cheng, A. F., T. K. Ling, A. W. Lam, K. S. Fung, and R. Wise. 1993. The antimicrobial activity and beta-lactamase stability of cefpirome, a new fourth-generation cephalosporin, in comparison with other agents. J. Antimicrob. Chemother. 31:699-709.
22. Cheymol, G. 2000. Effects of obesity on pharmacokinetics implications for drug therapy. Clin. Pharmacokinet. 39:215-231.
23. Cockcroft, D. W., and M. H. Gault. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41.
24. Craig, W. A. 1998. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin. Infect. Dis. 26:1-12.
25. Craig, W. A. 1993. The pharmacokinetics of cefpirome - rationale for a twelve-hour dosing regimen. Scand. J. Infect. Dis. Suppl. 91:33-40.
26. Cystic Fibrosis Foundation Patient Registry. 2002. 2001 Annual data report to the Center Directors. Cystic Fibrosis Foundation, Bethesda, MD.
27. Drusano, G. L. 2004. Antimicrobial pharmacodynamics: critical interactions of 'bug and drug'. Nat. Rev. Microbiol. 2:289-300.
28. Drusano, G. L. 2007. Pharmacokinetics and pharmacodynamics of antimicrobials. Clin. Infect. Dis. 45(Suppl)1:S89-S95.
29. Drusano, G. L., et al. 2001. Use of preclinical data for selection of a phase II/III dose for evernimicin and identification of a preclinical MIC breakpoint. Antimicrob. Agents Chemother. 45:13-22.
30. Elkhaïli, H., et al. 1998. Pharmacokinetics in vivo and pharmacodynamics ex vivo/in vitro of meropenem and cefpirome in the Yucatan micropig model: continuous infusion versus intermittent injection. Clin. Microbiol. Infect. 4:18-26.
31. European Committee on Antimicrobial Susceptibility Testing (EUCAST). 19 October 2010, accession date. Antimicrobial wild type distributions of microorganisms. European Committee on Antimicrobial Susceptibility Testing, Växjö, Sweden. http://www.escmid.org/research-projects/eucast/.
32. Fernandes, C., R. Pritchard, A. Morris, and R. Benn. 1998. In vitro evaluation of cefpirome: an Australasian study of isolates from intensive care unit and hematology/oncology patients. The Cefpirome Study Group. Diagn. Microbiol. Infect. Dis. 31:493-495.
33. Giamarellos-Bourboulis, E. J., P. Grecka, A. Tsitsika, C. Tympanidou, and H. Giamarellou. 2000. In-vitro activity of FK 037 (Cefoselis), a novel 4(th) generation cephalosporin, compared to cefepime and cefpirome on nosocomial staphylococci and gram-negative isolates. Diagn. Microbiol. Infect. Dis. 36:185-191.
34. Gibson, R. L., J. L. Burns, and B. W. Ramsey. 2003. Pathophysiology and management of pulmonary infections in cystic fibrosis. Am. J. Respir. Crit. Care Med. 168:918-951.
35. Goto, H., et al. 2006. Susceptibilities of bacteria isolated from patients with lower respiratory infectious diseases to antibiotics (2004). Jpn. J. Antibiot. 59:323-354. (In Japanese.)
36. Hancock, R. E., and F. Bellido. 1992. Factors involved in the enhanced efficacy against gram-negative bacteria of fourth generation cephalosporins. J. Antimicrob. Chemother. 29(Suppl. A):1-6.
37. Høiby, N., B. Frederiksen, and T. Pressler. 2005. Eradication of early Pseudomonas aeruginosa infection. J. Cyst. Fibros. 4(Suppl. 2):49-54.
38. Ishii, Y., J. Alba, S. Kimura, K. Shiroto, and K. Yamaguchi. 2005. Evaluation of antimicrobial activity of beta-lactam antibiotics using Etest against clinical isolates from 60 medical centres in Japan. Int. J. Antimicrob. Agents 25:296-301.
39. James, W. 1976. Research on obesity. Her Majesty's Stationery Office, London, United Kingdom.
40. Janmahasatian, S., et al. 2005. Quantification of lean bodyweight. Clin. Pharmacokinet. 44:1051-1065.
41. Kavi, J., J. M. Andrews, J. P. Ashby, G. Hillman, and R. Wise. 1988. Pharmacokinetics and tissue penetration of cefpirome, a new cephalosporin. J. Antimicrob. Chemother. 22:911-916.
42. Kumamoto, Y., et al. 2006. Comparative studies on activities of antimicrobial agents against causative organisms isolated from patients with urinary tract infections (2004). I. Susceptibility distribution. Jpn. J. Antibiot. 59:177-200. (In Japanese.)
43. Kumamoto, Y., et al. 2005. Comparative studies on activities of antimicrobial agents against causative organisms isolated from patients with urinary tract infections (2003). III. Secular changes in susceptibility. Jpn. J. Antibiot. 58:557-654. (In Japanese.)
44. Lewis, M. T., K. Yamaguchi, D. J. Biedenbach, and R. N. Jones. 1999. In vitro evaluation of cefepime and other broad-spectrum beta-lactams in 22 medical centers in Japan: a phase II trial comparing two annual organism samples. The Japan Antimicrobial Resistance Study Group. Diagn. Microbiol. Infect. Dis. 35:307-315.
45. Liassine, N., et al. 1997. In vitro activity of cefpirome against microorganisms isolated in haematology, oncology and intensive care units in Switzerland. Scand. J. Infect. Dis. 29:615-621.
46. Maass, L., et al. 1987. Dose linearity testing of intravenous cefpirome (HR 810), a novel cephalosporin derivate. Infection 15:202-206. (Pubitemid 17084974)
47. MacKenzie, F. M., et al. 2004. Antibiograms of resistant Gram-negative bacteria from Scottish CF patients. J. Cyst. Fibros. 3:151-157.
48. Malerczyk, V., et al. 1987. Single and multiple dose pharmacokinetics of intravenous cefpirome (HR 810), a novel cephalosporin derivative. Infection 15:211-214. (Pubitemid 17084976)
49. Mammeri, H., L. Poirel, P. Bemer, H. Drugeon, and P. Nordmann. 2004. Resistance to cefepime and cefpirome due to a 4-amino-acid deletion in the chromosome-encoded AmpC beta-lactamase of a Serratia marcescens clinical isolate. Antimicrob. Agents Chemother. 48:716-720.
50. Mathai, D., P. R. Rhomberg, D. J. Biedenbach, and R. N. Jones. 2002. Evaluation of the in vitro activity of six broad-spectrum beta-lactam antimicrobial agents tested against recent clinical isolates from India: a survey of ten medical center laboratories. Diagn. Microbiol. Infect. Dis. 44:367-377.
51. Matthews, I., C. Kirkpatrick, and N. Holford. 2004. Quantitative justification for target concentration intervention - parameter variability and predictive performance using population pharmacokinetic models for aminoglycosides. Br. J. Clin. Pharmacol. 58:8-19.
52. Miller, M. E., and D. M. Kornhauser. 1994. Bromide pharmacokinetics in cystic fibrosis. Arch. Pediatr. Adolesc. Med. 148:266-271.
53. Müller, M., et al. 1997. Relationship between serum and free interstitial concentrations of cefodizime and cefpirome in muscle and subcutaneous adipose tissue of healthy volunteers measured by microdialysis. J. Clin. Pharmacol. 37:1108-1113.
54. Nakayama, I., et al. 1992. Single- and multiple-dose pharmacokinetics of intravenous cefpirome (HR810) to healthy volunteers. J. Clin. Pharmacol. 32:256-266.
55. Nikaido, H., W. Liu, and E. Y. Rosenberg. 1990. Outer membrane permeability and beta-lactamase stability of dipolar ionic cephalosporins containing methoxyimino substituents. Antimicrob. Agents Chemother. 34:337-342.
56. Payne, D. J., M. N. Gwynn, D. J. Holmes, and D. L. Pompliano. 2007. Drugs for bad bugs: confronting the challenges of antibacterial discovery. Nat. Rev. Drug Discov. 6:29-40.
57. Piérard, D., K. Emmerechts, and S. Lauwers. 1998. Comparative in-vitro activity of cefpirome against isolates from intensive care and haematology/oncology units. Belgian Multicentre Study Group. J. Antimicrob. Chemother. 41:443-450.
58. Rey, E., J. M. Treluyer, and G. Pons. 1998. Drug disposition in cystic fibrosis. Clin. Pharmacokinet. 35:313-329.
59. Roos, J. F., J. Lipman, and C. M. Kirkpatrick. 2007. Population pharmacokinetics and pharmacodynamics of cefpirome in critically ill patients against Gram-negative bacteria. Intensive Care Med. 33:781-788.
60. Sanders, C. C. 1993. Cefepime: the next generation? Clin. Infect. Dis. 17:369-379.
61. Sauermann, R., et al. 2005. Pharmacokinetics and pharmacodynamics of cefpirome in subcutaneous adipose tissue of septic patients. Antimicrob. Agents Chemother. 49:650-655.
62. Shimada, K., et al. 2004. Susceptibilities of bacteria isolated from patients with lower respiratory infectious diseases to antibiotics (2002). Jpn. J. Antibiot. 57:213-245. (In Japanese.)
63. Strenkoski, L. C., and D. E. Nix. 1993. Cefpirome clinical pharmacokinetics. Clin. Pharmacokinet. 25:263-273.
64. Suzuki, Y., et al. 1996. Antibacterial activities of combination uses of cefpirome with various antibiotics in vitro against clinically isolated glucose non-fermentative gram-negative rods: part 1. The results against Pseudomonas aeruginosa. Jpn. J. Antibiot. 49:71-82. (In Japanese.)
65. Touw, D. J., A. A. Vinks, H. G. Heijerman, and W. Bakker. 1996. Prospective evaluation of a dose prediction algorithm for intravenous tobramycin in adolescent and adult patients with cystic fibrosis. Ther. Drug Monit. 18:118-123.
66. Touw, D. J., A. A. Vinks, J. W. Mouton, and A. M. Horrevorts. 1998. Pharmacokinetic optimisation of antibacterial treatment in patients with cystic fibrosis. Current practice and suggestions for future directions. Clin. Pharmacokinet. 35:437-459.
67. Vinks, A. A., R. N. van Rossem, R. A. Mathot, H. G. Heijerman, and J. W. Mouton. 2007. Pharmacokinetics of aztreonam in healthy subjects and patients with cystic fibrosis and evaluation of dose-exposure relationships using Monte Carlo simulation. Antimicrob. Agents Chemother. 51:3049-3055.