Quantitative clinical pharmacology practice for optimal use of antibiotics during the neonatal period

Expert Opinion on Drug Metabolism and Toxicology

Volumn 12, Issue 4, 2016, Pages 367-375

  Samardzic, Janko ^a,b   Allegaert, Karel ^c,d   Wilbaux, Mélanie ^b   Pfister, Marc ^b   Van Den Anker, John N ^b,d,e  

^a UNIVERSITY OF BELGRADE   (Serbia)

^b UNIVERSITY OF BASEL   (Switzerland)

^c UNIVERSITY OF LEUVEN   (Belgium)

^d SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^e CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

Author keywords

Antibiotics; clinical pharmacology; modeling and simulation; neonate; pharmacometrics; therapeutic drug monitoring

Indexed keywords

ANTIBIOTIC AGENT; VANCOMYCIN; ANTIINFECTIVE AGENT;

ANTIBIOTIC THERAPY; CLINICAL PHARMACOLOGY; CLINICAL PRACTICE; DRUG MONITORING; DRUG USE; HUMAN; KIDNEY FUNCTION; NEWBORN; NEWBORN INFECTION; NEWBORN PERIOD; QUANTITATIVE ANALYSIS; REVIEW; SIMULATION; BAYES THEOREM; BIOLOGICAL MODEL; CLINICAL DECISION MAKING; COMMUNICABLE DISEASES; DOSE RESPONSE; DRUG EFFECTS; KIDNEY; METABOLISM; NEONATOLOGY; PROCEDURES;

ANTI-BACTERIAL AGENTS; BAYES THEOREM; CLINICAL DECISION-MAKING; COMMUNICABLE DISEASES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; HUMANS; INFANT, NEWBORN; KIDNEY; MODELS, BIOLOGICAL; NEONATOLOGY; VANCOMYCIN;

EID: 84958045122     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2016.1147559     Document Type: Review

References (82)

1. Van den Anker JN, Schwab M, Kearns GL. Developmental pharmacokinetics. Handb Exp Pharmacol. 2011; 205: 51-75.
2. Samardzic J, Allegaert K, Bajcetic M. Developmental pharmacology: A moving target. Int J Pharm. 2015; 492: 335-337.
3. Williams K, Thomson D, Seto I, et al. Standard 6: Age groups for pediatric trials. Pediatrics. 2012; 129: S153-60.
4. Leekha S, Terrell CL, Edson RS. General principles of antimicrobial therapy. Mayo Clin Proceed. 2011; 86: 156-167.
5. Yaffe SJ, Aranda JV. Neonatal and pediatric pharmacology: Therapeutic principles in practice. 4th ed. Philadelphia (PA): Lippincott Williams Wilkins; 2011.
6. Black RE, Cousens S, Johnson HL, et al. Global, regional, and national causes of child mortality in 2008: A systematic analysis. Lancet. 2010; 375: 1969-1987.
7. Kaufman D, Fairchild KD. Clinical microbiology ofbacterial and fungal sepsis in very-low-birth-weight infants. Clin Microbiol Rev. 2004; 17: 638-680.
8. Ohlin A, Björkman L, Serenius F, et al. Sepsis as a risk factor for neonatal morbidity in extremely preterm infants. Acta Paediatr. 2015. doi: 10.1111/apa.13104.
9. Remington JS, Klein JO, Wilson CB, et al. Infectious diseases of the fetus and newborn infant. 7th. Philadelphia (PA): Elsevier Saunders; 2011.
10. Stoll BJ, Gordon T, Korones SB, et al. Late-onset sepsis in very low birth weight neonates: A report from the national institute of child health and human development neonatal research network. J Pediatr. 1996; 129: 63-71.
11. Stoll BJ, Hansen NI, Sanchez PJ, et al. Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. early onset sepsis: The Burden of Group B streptococcal and E. Coli disease continues. Pediatrics. 2011; 127: 817-826.
12. van den Anker JN. How to optimize the evaluation and use of antibiotics in neonates. Early Hum Dev. 2014; 90: S10-2.
13. MacDonald MG, Mullett MD, Seshia MMK. Averys neonatology: pathophysiology & management of the newborn. 6th ed. Philadelphia (PA): Lippincott Williams & Wilkins; 2005.
14. Sherwin CM, Medlicott NJ, Reith DM, et al. Intravenous drug delivery in neonates: lessons learnt. Arch Dis Child. 2014; 99: 590-594.
15. Allegaert K, Anderson BJ, Vrancken M, et al. Impact of a paediatric vial on the magnitude of systematic medication errors in neonates. Paediatr Perinat Drug Ther. 2006; 7: 59-63.
16. Samardzic J, Turner MA, Bax R, et al. Neonatal medicines research: challenges and opportunities. Expert Opin Drug Metab Toxicol. 2015; 11: 1041-1052.
17. Ulldemolins M, Roberts JA, Rello J, et al. The effects of hypoalbuminaemia on optimizing antibacterial dosing in critically ill patients. Clin Pharmacokinet. 2011; 50: 99-110.
18. Roberts JA, Pea F, Lipman J. The clinical relevance of plasma protein binding changes. Clin Pharmacokinet. 2013; 52: 1-8.
19. Zeitlinger MA, Sauermann R, Traunmüller F, et al. Impact of plasma protein binding on antimicrobial activity using time-killing curves. J Antimicrob Chemother. 2004; 54: 876-880.
20. Smits A, Kulo A, Verbesselt R, et al. Cefazolin plasma protein binding and its covariates in neonates. Eur J Clin Microbiol Infect Dis. 2012; 31: 3359-3365.
21. Pullen J, Stolk LM, Degraeuwe PL, et al. Protein binding of flucloxacillin in neonates. Ther Drug Monit. 2007; 29: 279-283.
22. Hines RN. Developmental expression of drug metabolizing enzymes: impact on disposition in neonates and young children. Int J Pharm. 2013; 452: 3-7.
23. Ahsman MJ, Wildschut ED, Tibboel D, et al. Pharmacokinetics of cefotaxime and desacetylcefotaxime in infants during extracorporeal membrane oxygenation. Antimicrob Agents Chemother. 2010; 54: 1734-1741.
24. Schreuder MF, Bueters RR, Allegaert K. The interplay between drugs and the kidney in premature neonates. Pediatr Nephrol. 2014; 29: 2083-2091.
25. Vieux R, Hascoet JM, Merdariu D, et al. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010; 125: e1186-92.
26. De Cock RF, Allegaert K, Sherwin CM, et al. A neonatal amikacin covariate model can be used to predict ontogeny of other drugs eliminated through glomerular filtration in neonates. Pharm Res. 2014; 31: 754-767.
27. De Cock RF, Allegaert K, Brussee JM, et al. Simultaneous pharmacokinetic modeling of gentamicin, tobramycin and vancomycin clearance from neonates to adults: Towards a semi-physiological function for maturation in glomerular filtration. Pharm Res. 2014; 31: 2643-2654.
28. Rhodin MM, Anderson BJ, Peters AM, et al. Human renal function maturation: A quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009; 24: 67-76.
29. De Cock RF, Allegaert K, Schreuder MF, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet. 2012; 51: 105-117.
30. Bueters RR, Kusters LJ, Klaasen A, et al. Antibiotics and renal branching morphogenesis: comparison of toxicities. Pediatr Res. 2014; 76: 508-514.
31. Girardi A, Raschi E, Galletti S, et al. Drug-induced renal damage in preterm neonates: state of the art and methods for early detection. Drug Saf. 2015; 38: 535-551.
32. Yaffe SJ, Aranda JV, Van Den Anker JN. Neonatal and pediatric pharmacology: Therapeutic principles in practice. 3rd ed. Philadelphia: Lippincott Williams Wilkins; 2005.
33. Chen N, Aleksa K, Woodland C, et al. Ontogeny of drug elimination by the human kidney. Pediatr Nephrol. 2006; 21: 160-168.
34. Engle WA. American Academy of Pediatrics Committee on Fetus and Newborn. Age Terminology during the Perinatal Period. Pediatrics. 2004; 114: 1362-1364.
35. Rodieux F, Wilbaux M, van den Anker JN, et al. Effect of kidney function on drug kinetics and dosing in neonates, infants, and children. Clin Pharmacokinet. 2015;54:1183-1204.
36. Schwartz GJ, Haycock GB, Edelmann CM Jr, et al. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976; 58: 259-263.
37. Kandasamy Y, Smith R, Wright IM. Measuring cystatin C to determine renal function in neonates. Pediatr Crit Care Med. 2013; 14: 318-322.
38. Brou NA, Jacqz-Aigrain E, Zhao W. Cystatin C as a potential biomarker for dosing of renally excreted drugs. Br J Clin Pharmacol. 2015; 80: 20-27.
39. Pfister M, DArgenio DZ. The emerging scientific discipline of pharmacometrics. J Clin Pharmacol. 2010; 50: 6S.
40. De Cock RF, Piana C, Krekels EH, et al. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011; 67: 5-16.
41. van der Graaf PH. CPT: pharmacometrics and systems pharmacology. CPT Pharmacomet Syst Pharmacol. 2012; 1: e8.
42. Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development-part 2: introduction to pharmacokinetic modeling methods. CPT Pharmacomet Syst Pharmacol. 2013; 2: e38.
43. Johnson TN, Rostami-Hodjegan A. Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice. Paediatr Anaesth. 2011; 21: 291-301.
44. Jones H, Rowland-Yeo K. Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development. CPT Pharmacomet Syst Pharmacol. 2013; 2: e63.
45. Sheiner LB. The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods. Drug Metab Rev. 1984; 15: 153-171.
46. Capparelli EV, Lane JR, Romanowski GL, et al. The influences of renal function and maturation on vancomycin elimination in newborns and infants. J Clin Pharmacol. 2001; 41: 927-934.
47. Allegaert K, Anderson BJ, Van Den Anker JN, et al. Renal drug clearance in preterm neonates: relation to prenatal growth. Ther Drug Monit. 2007; 29: 284-291.
48. Smith PB, Cohen-Wolkowiez M, Castro LM, et al. Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-Abdominal infections. Pediatr Infect Dis J. 2011; 30: 844-849.
49. Van den Anker JN, Pokorna P, Kinzig-Schippers M, et al. Meropenem pharmacokinetics in the newborn. Antimicrob Agents Chemother. 2009; 53: 3871-3879.
50. Fuchs A, Guidi M, Giannoni E, et al. Population pharmacokinetic study of gentamicin in a large cohort of premature and term neonates. Br J Clin Pharmacol. 2014; 78: 1090-1101.
51. Golper TA, Noonan HM, Elzinga L, et al. Vancomycin pharmacokinetics, renal handling, and nonrenal clearances in normal human subjects. Clin Pharmacol Ther. 1988; 43: 565-570.
52. Liu C, Bayer A, Cosgrove SE, et al. 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. 2011; 52: e18-55.
53. Jacqz-Aigrain E, Zhao W, Sharland M, et al. Use of antibacterial agents in the neonate: 50 years of experience with vancomycin administration. Semin Fetal Neonatal Med. 2013; 18: 28-34.
54. Vandendriessche A, Allegaert K, Cossey V, et al. Prospective validation of neonatal vancomycin dosing regimens is urgently needed. Curr Ther Res Clin Exp. 2014; 76: 51-57.
55. Jacqz-Aigrain E, Leroux S, Zhao W, et al. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015; 8: 635-648.
56. Bhongsatiern JJ, Stockmann C, Yu T, et al. Renal function descriptors in neonates: which creatinine-based formula best describes vancomycin clearance? J Clin Pharmacol. 2015. doi: 10.1002/jcph.650.
57. Kimura T, Sunakawa K, Matsuura N, et al. Population pharmacokinetics of arbekacin, vancomycin, and panipenem in neonates. Antimicrob Agents Chemother. 2004; 48: 1159-1167.
58. Mehrotra N, Tang L, Phelps SJ, et al. Evaluation of vancomycin dosing regimens in preterm and term neonates using Monte Carlo simulations. Pharmacotherapy. 2012; 32: 408-419.
59. Zhao W, Lopez E, Biran V, et al. Vancomycin continuous infusion in neonates: dosing optimisation and therapeutic drug monitoring. Arch Dis Child. 2013; 98: 449-453.
60. Frymoyer A, Hersh AL, El-Komy MH, et al. Association between vancomycin trough concentration and area under the concentration-Time curve in neonates. Antimicrob Agents Chemother. 2014; 58: 6454-6461.
61. Roberts JA, Lipman J. Antibacterial dosing in intensive care: pharmacokinetics, degree of disease and pharmacodynamics of sepsis. Clin Pharmacokinet. 2006; 45: 755-773.
62. Mulla H. Understanding developmental pharmacodynamics: importance for drug development and clinical practice. Paediatr Drugs. 2010; 12: 223-233.
63. Dunne J, Rodriguez WJ, Murphy MD, et al. Extrapolation of adult data and other data in pediatric drug-development programs. Pediatrics. 2011; 128: e1242-9.
64. Kent A, Turner MA, Sharland M, et al. Aminoglycoside toxicity in neonates: something to worry about ? Expert Rev Anti Infect Ther. 2014; 12: 319-331.
65. Standing JF, Tuleu C. Paediatric formulations-Getting to the heart of the problem. Int J Pharm. 2005; 300: 56-66.
66. de Wildt SN. Profound changes in drug metabolism enzymes and possible effects on drug therapy in neonates and children. Expert Opin Drug Metab Toxicol. 2011; 7: 935-948.
67. de Lange DW. Glomerular hyperfiltration of antibiotics. Neth J Crit Care. 2013; 17: 10-14.
68. de Cock P, Standing J, Barker C, et al. Augmented renal clearance implies a need for increased amoxicillin-clavulanate dosing in critically ill children. Arch Dis Child. 2016; 101: e1.
69. Chytra I, Stepan M, Benes J, et al. Clinical and microbiological efficacy of continuous versus intermittent application of meropenem in critically ill patients: A randomized open-label controlled trial. Crit Care. 2012; 16: R113.
70. Tröger U, Drust A, Martens-Lobenhoffer J, et al. Decreased meropenem levels in Intensive Care Unit patients with augmented renal clearance: benefit of therapeutic drug monitoring. Int J Antimicrob Agents. 2012; 40: 370-372.
71. Udy AA, Varghese JM, Altukroni M, et al. Subtherapeutic initial β-lactam concentrations in select critically ill patients: Association between augmented renal clearance and low trough drug concentrations. Chest. 2012; 142: 30-39.
72. Prowle JR, Molan MP, Hornsey E, et al. Measurement of renal blood flow by phase-contrast magnetic resonance imaging during septic acute kidney injury: A pilot investigation. Crit Care Med. 2012; 40: 1768-1776.
73. van den Anker JN, Allegaert K. Pharmacokinetics of aminoglycosides in the newborn. Curr Pharm Des. 2012; 18: 3114-3118.
74. Kadambari S, Heath PT, Sharland M, et al. Variation in gentamicin and vancomycin dosage and monitoring in UK neonatal units. J Antimicrob Chemother. 2011; 66: 2647-2650.
75. De Hoog M, Mouton JW, van den Anker JN. Vancomycin: pharmacokinetics and administration regimens in neonates. Clin Pharmacokinet. 2004; 43: 417-440.
76. Zhao W, Kaguelidou F, Biran V, et al. External evaluation of population pharmacokinetic models of vancomycin in neonates: The transferability of published models to different clinical settings. Br J Clin Pharmacol. 2013; 75: 1068-1080.
77. Samardzic J, Smits A, Cossey V, et al. To what extent does the vancomycin assay contribute to the variability in vancomycin concentration estimates in neonates? Arch Dis Child. 2016; 101: e1.
78. Allegaert K, van den Anker JN., Creatinine-based vancomycin dosing regimens in neonates: There is more to consider than the variation in drug assay. Pharmacotherapy. 2012; 32: e174. discussion e175.
79. Allegaert K, van den Anker JN. Adverse drug reactions in neonates and infants: A population-Tailored approach is needed. Br J Clin Pharmacol. 2015; 80: 788-795.
80. Metsvaht T, Nellis G, Varendi H, et al. High variability in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination. BMC Pediatr. 2015; 15: 41.
81. Smits A, De Cock RF, Allegaert K, et al. Prospective evaluation of a model-based dosing regimen for amikacin in preterm and term neonates in clinical practice. Antimicrob Agents Chemother. 2015; 59: 6344-6351.
82. Ramos-Martín V, Johnson A, Livermore J, et al. Pharmacodynamics of vancomycin for CoNS infection: experimental basis for optimal use of vancomycin in neonates. J Antimicrob Chemother. 2016. doi: 10.1093/jac/dkv451.