External evaluation of population pharmacokinetic models of vancomycin in neonates: The transferability of published models to different clinical settings

British Journal of Clinical Pharmacology

Volumn 75, Issue 4, 2013, Pages 1068-1080

  Zhao, Wei ^a,b   Kaguelidou, Florentia ^a,b,c   Biran, Valérie ^a,c   Zhang, Daolun ^a   Allegaert, Karel ^d   Capparelli, Edmund V ^e   Holford, Nick ^f   Kimura, Toshimi ^g   Lo, Yoke Lin ^h   Peris, José Esteban ⁱ   Thomson, Alison ^j,k   van den Anker, John N ^l   Fakhoury, May ^a   Jacqz Aigrain, Evelyne ^a,b,c  

^a HÔPITAL ROBERT DEBRÉ   (France)

^b ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f UNIVERSITY OF AUCKLAND   (New Zealand)

^g TOKYO WOMEN S MEDICAL UNIVERSITY MEDICAL CENTER EAST   (Japan)

^h UNIVERSITY OF MALAYA   (Malaysia)

ⁱ UNIVERSITY OF VALENCIA   (Spain)

^j UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^k WESTERN INFIRMARY   (United Kingdom)

^l GEORGE WASHINGTON UNIVERSITY   (United States)

more..

Author keywords

Dosing regimen; External evaluation; Neonates; Population pharmacokinetics; Serum creatinine; Vancomycin

Indexed keywords

CREATININE; VANCOMYCIN; ANTIINFECTIVE AGENT;

ARTICLE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG SCREENING; HUMAN; NEWBORN; NEWBORN CARE; PREMATURITY; PRIORITY JOURNAL; STEADY STATE; BIOLOGICAL MODEL; BLOOD; COMPUTER SIMULATION; DOSE RESPONSE; DRUG ADMINISTRATION; GESTATIONAL AGE; PREDICTIVE VALUE;

ANTI-BACTERIAL AGENTS; COMPUTER SIMULATION; CREATININE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; GESTATIONAL AGE; HUMANS; INFANT, NEWBORN; MODELS, BIOLOGICAL; PREDICTIVE VALUE OF TESTS; VANCOMYCIN;

EID: 84875069843     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04406.x     Document Type: Article

References (48)

1. de Hoog M, Mouton JW, van den Anker JN. Vancomycin: pharmacokinetics and administration regimens in neonates. Clin Pharmacokinet 2004; 43: 417-440.
2. Sun H, Maderazo EG, Krusell AR. Serum protein-binding characteristics of vancomycin. Antimicrob Agents Chemother 1993; 37: 1132-1136.
3. Lundstrom TS, Sobel JD. Antibiotics for gram-positive bacterial infections: vancomycin, quinupristin-dalfopristin, linezolid, and daptomycin. Infect Dis Clin North Am 2004; 18: 651-668.
4. Golper TA, Noonan HM, Elzinga L, Gilbert D, Brummett R, Anderson JL, Bennett WM. Vancomycin pharmacokinetics, renal handling, and nonrenal clearances in normal human subjects. Clin Pharmacol Ther 1988; 43: 565-570.
5. Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet 2004; 43: 925-942.
6. Martin JH, Norris R, Barras M, Roberts J, Morris R, Doogue M, Jones GR. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society Of Infectious Diseases Pharmacists. Clin Biochem Rev 2010; 31: 21-24.
7. Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population (CHMP/EWP/147013/04 Corrigendum). 2006. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003066.pdf (last accessed 3 September 2012).
8. Anderson BJ, Allegaert K, Van den Anker JN, Cossey V, Holford NH. Vancomycin pharmacokinetics in preterm neonates and the prediction of adult clearance. Br J Clin Pharmacol 2007; 63: 75-84.
9. Allegaert K, Anderson BJ, van den Anker JN, Vanhaesebrouck S, de Zegher F. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit 2007; 29: 284-291.
10. Kimura T, Sunakawa K, Matsuura N, Kubo H, Shimada S, Yago K. Population pharmacokinetics of arbekacin, vancomycin, and panipenem in neonates. Antimicrob Agents Chemother 2004; 48: 1159-1167.
11. Lo YL, van Hasselt JG, Heng SC, Lim CT, Lee TC, Charles BG. Population pharmacokinetics of vancomycin in premature Malaysian neonates: identification of predictors for dosing determination. Antimicrob Agents Chemother 2010; 54: 2626-2632.
12. Marqués-Miñana MR, Saadeddin A, Peris JE. Population pharmacokinetic analysis of vancomycin in neonates. A new proposal of initial dosage guideline. Br J Clin Pharmacol 2010; 70: 713-720.
13. Capparelli EV, Lane JR, Romanowski GL, McFeely EJ, Murray W, Sousa P, Kildoo C, Connor JD. The influences of renal function and maturation on vancomycin elimination in newborns and infants. J Clin Pharmacol 2001; 41: 927-934.
14. Mulla H, Pooboni S. Population pharmacokinetics of vancomycin in patients receiving extracorporeal membrane oxygenation. Br J Clin Pharmacol 2005; 60: 265-275.
15. Seay RE, Brundage RC, Jensen PD, Schilling CG, Edgren BE. Population pharmacokinetics of vancomycin in neonates. Clin Pharmacol Ther 1994; 56: 169-175.
16. de Hoog M, Schoemaker RC, Mouton JW, van den Anker JN. Vancomycin population pharmacokinetics in neonates. Clin Pharmacol Ther 2000; 67: 360-367.
17. Grimsley C, Thomson AH. Pharmacokinetics and dose requirements of vancomycin in neonates. Arch Dis Child Fetal Neonatal Ed 1999; 81: F221-227.
18. Lebel D, Ducharme MP. A population pharmacokinetic model for vancomycin in pediatric patients and its predictive value in a naive population. Antimicrob Agents Chemother 2000; 44: 278-282.
19. Silva R, Reis E, Bispo MA, Almeida AM, Costa IM, Falcão F, Palminha JM, Falcão AC. The kinetic profile of vancomycin in neonates. J Pharm Pharmacol 1998; 50: 1255-1260.
20. Oudin C, Vialet R, Boulamery A, Martin C, Simon N. Vancomycin prescription in neonates and young infants: toward a simplified dosage. Arch Dis Child Fetal Neonatal Ed 2011; 96: 365-370.
21. Mehrotra N, Tang L, Phelps SJ, Meibohm B. Evaluation of vancomycin dosing regimens in preterm and term neonates using monte carlo simulations. Pharmacotherapy 2012; 32: 408-419.
22. McDougal A, Ling EW, Levine M. Vancomycin pharmacokinetics and dosing in premature neonates. Ther Drug Monit 1995; 17: 319-326.
23. Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet 2008; 47: 231-243.
24. Marsot A, Boulamery A, Bruguerolle B, Simon N. Vancomycin: a review of population pharmacokinetic analyses. Clin Pharmacokinet 2012; 51: 1-13.
25. Bergstrand M, Karlsson MO. Handling data below the limit of quantification in mixed effect models. AAPS J 2009; 11: 371-380.
26. Mongelli M, Biswas A. A fetal growth standard derived from multiple modalities. Early Hum Dev 2001; 60: 171-177.
27. Emit® 2000 Vancomycin Assay, Syva®, Dade Behring 2002.
28. Vancomycin, Cobas Integra 400/800, Roche 2006.
29. Brendel K, Comets E, Laffont C, Laveille C, Mentré F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res 2006; 23: 2036-2049.
30. Comets E, Brendel K, Mentré F. Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R. Comput Methods Programs Biomed 2008; 90: 154-166.
31. Prigent A. Monitoring renal function and limitations of renal function tests. Semin Nucl Med 2008; 38: 32-46.
32. Perrone RD, Madias NE, Levey AS. Serum creatinine as an index of renal function: new insights into old concepts. Clin Chem 1992; 38: 1933-1953.
33. Bellanti F, Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol 2011; 67: 75-86.
34. FDA guidance for industry: exposure-response relationships - study design, data analysis, and regulatory applications. 2003. Available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf (last accessed 3 September 2012).
35. Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (Doc. Ref. CPMP/EWP/2655/99). 2000. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003420.pdf (last accessed 3 September 2012).
36. Guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2). 2011. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003417.pdf (last accessed 3 September 2012).
37. De Cock RF, Piana C, Krekels EH, Danhof M, Allegaert K, Knibbe CA. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol 2011; 67: 5-16.
38. Ince I, de Wildt SN, Tibboel D, Danhof M, Knibbe CA. Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today 2009; 14: 316-320.
39. van den Anker JN. Renal function in preterm infants. Eur J Pediatr 1997; 156: 583-584.
40. Peake M, Whiting M. Measurement of serum creatinine - current status and future goals. Clin Biochem Rev 2006; 27: 173-184.
41. Allegaert K, Kuppens M, Mekahli D, Levtchenko E, Vanstapel F, Vanhole C, van den Anker JN. Creatinine reference values in ELBW infants: impact of quantification by Jaffe or enzymatic method. J Matern Fetal Neonatal Med (in press).
42. Kuppens M, George I, Lewi L, Levtchenko E, Allegaert K. Creatinaemia at birth is equal to maternal creatinaemia at delivery: does this paradigm still hold? J Matern Fetal Neonatal Med 2012; 25: 1678-1681.
43. Anne L, Hu M, Chan K, Colin L, Gottwald K. Potential problem with fluorescence polarization immunoassay cross-reactivity to vancomycin degradation product CDP-1: its detection in sera of renally impaired patients. Ther Drug Monit 1989; 11: 585-591.
44. Smith PF, Morse GD. Accuracy of measured vancomycin serum concentrations in patients with end-stage renal disease. Ann Pharmacother 1999; 33: 1329-1335.
45. Iwamoto T, Kagawa Y, Kojima M. Factors influencing the overestimation of plasma vancomycin concentrations measured by the Abbott TDx technique. Ther Drug Monit 2005; 27: 58-62.
46. Berthoin K, Ampe E, Tulkens PM, Carryn S. Correlation between free and total vancomycin serum concentrations in patients treated for Gram-positive infections. Int J Antimicrob Agents 2009; 34: 555-560.
47. Krekels EH, DeJongh J, van Lingen RA, van der Marel CD, Choonara I, Lynn AM, Danhof M, Tibboel D, Knibbe CA. Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of (preterm) neonates, infants and children. Clin Pharmacokinet 2011; 50: 51-63.
48. van den Anker JN. Getting the dose of vancomycin right in the neonate. Int J Clin Pharmacol Ther 2011; 49: 247-249.