Population pharmacokinetics of vancomycin in term neonates with perinatal asphyxia treated with therapeutic hypothermia.
antimicrobial therapy
neonates
perinatal asphyxia
pharmacokinetics
therapeutic hypothermia
vancomycin
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
07 Mar 2024
07 Mar 2024
Historique:
revised:
18
01
2024
received:
06
11
2023
accepted:
31
01
2024
medline:
7
3
2024
pubmed:
7
3
2024
entrez:
7
3
2024
Statut:
aheadofprint
Résumé
Little is known about the population pharmacokinetics (PPK) of vancomycin in neonates with perinatal asphyxia treated with therapeutic hypothermia (TH). We aimed to describe the PPK of vancomycin and propose an initial dosing regimen for the first 48 h of treatment with pharmacokinetic/pharmacodynamic target attainment. Neonates with perinatal asphyxia treated with TH were included from birth until Day 6 in a multicentre prospective cohort study. A vancomycin PPK model was constructed using nonlinear mixed-effects modelling. The model was used to evaluate published dosing guidelines with regard to pharmacokinetic/pharmacodynamic target attainment. The area under the curve/minimal inhibitory concentration ratio of 400-600 mg*h/L was used as target range. Sixteen patients received vancomycin (median gestational age: 41 [range: 38-42] weeks, postnatal age: 4.4 [2.5-5.5] days, birth weight: 3.5 [2.3-4.7] kg), and 112 vancomycin plasma concentrations were available. Most samples (79%) were collected during the rewarming and normothermic phase, as vancomycin was rarely initiated during the hypothermic phase due to its nonempirical use. An allometrically scaled 1-compartment model showed the best fit. Vancomycin clearance was 0.17 L/h, lower than literature values for term neonates of 3.5 kg without perinatal asphyxia (range: 0.20-0.32 L/h). Volume of distribution was similar. Published dosing regimens led to overexposure within 24 h of treatment. A loading dose of 10 mg/kg followed by 24 mg/kg/day in 4 doses resulted in target attainment. Results of this study suggest that vancomycin clearance is reduced in term neonates with perinatal asphyxia treated with TH. Lower dosing regimens should be considered followed by model-informed precision dosing.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : ZonMw
ID : 40-41500-98-9002
Pays : Netherlands
Organisme : ZonMw
ID : 40-41500-98-9002
Pays : Netherlands
Informations de copyright
© 2024 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.
Références
Pacifici GM, Allegaert K. Clinical pharmacokinetics of vancomycin in the neonate: a review. Clinics (Sao Paulo). 2012;67(7):831-837. doi:10.6061/clinics/2012(07)21
Hughes JH, Tong DMH, Faldasz JD, Frymoyer A, Keizer RJ. Evaluation of neonatal and paediatric vancomycin pharmacokinetic models and the impact of maturation and serum creatinine covariates in a large multicentre data set. Clin Pharmacokinet. 2023;62(1):67-76. doi:10.1007/s40262-022-01185-4
Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-system Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2020;71(6):1361-1364. doi:10.1093/cid/ciaa303
Gupta BD, Sharma P, Bagla J, Parakh M, Soni JP. Renal failure in asphyxiated neonates. Indian Pediatr. 2005;42(9):928-934.
Langeslag J, Onland W, Visser D, et al. Predictive performance of multiple organ dysfunction in asphyxiated newborns treated with therapeutic hypothermia on 24-month outcome: a cohort study. Arch Dis Child Fetal Neonatal Ed. 2023;109(1):41-45. doi:10.1136/archdischild-2023-325585
Dao K, Guidi M, André P, et al. Optimisation of vancomycin exposure in neonates based on the best level of evidence. Pharmacol Res. 2020;154:104278. doi:10.1016/j.phrs.2019.104278
de Haan TR, Bijleveld YA, van der Lee JH, et al. Pharmacokinetics and pharmacodynamics of medication in asphyxiated newborns during controlled hypothermia. The PharmaCool multicenter study. BMC Pediatr. 2012;12(1):45. doi:10.1186/1471-2431-12-45
Shankaran S, Laptook AR, Ehrenkranz RA, et al. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005;353(15):1574-1584. doi:10.1056/NEJMcps050929
Shah PS, Beyene J, To T, Ohlsson A, Perlman M. Postasphyxial hypoxic-ischemic encephalopathy in neonates: outcome prediction rule within 4 hours of birth. Arch Pediatr Adolesc Med. 2006;160(7):729-736. doi:10.1001/archpedi.160.7.729
Bijleveld YA, de Haan TR, van der Lee HJ, et al. Altered gentamicin pharmacokinetics in term neonates undergoing controlled hypothermia. Br J Clin Pharmacol. 2016;81(6):1067-1077. doi:10.1111/bcp.12883
van der Veer MAA, de Haan TR, Franken LGW, et al. Population pharmacokinetics and dosing optimization of ceftazidime in term asphyxiated neonates during controlled therapeutic hypothermia. Antimicrob Agents Chemother. 2023;67(5):e0170722. doi:10.1128/aac.01707-22
Dutch Pediatric Formulary. Vancomycin. 2023. Accessed October 8, 2023. https://www.kinderformularium.nl/geneesmiddel/337/vancomycine
Bijleveld Y, de Haan T, Toersche J, et al. A simple quantitative method analysing amikacin, gentamicin, and vancomycin levels in human newborn plasma using ion-pair liquid chromatography/tandem mass spectrometry and its applicability to a clinical study. J Chromatogr B Analyt Technol Biomed Life Sci. 2014;951-952:110-118. doi:10.1016/j.jchromb.2014.01.035
Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development-part 2: introduction to pharmacokinetic modeling methods. CPT Pharmacometrics Syst Pharmacol. 2013;2(4):e38. doi:10.1038/psp.2013.14
Holford N, Heo YA, Anderson B. A pharmacokinetic standard for babies and adults. J Pharm Sci. 2013;102(9):2941-2952. doi:10.1002/jps.23574
Germovsek E, Barker CI, Sharland M, Standing JF. Scaling clearance in paediatric pharmacokinetics: all models are wrong, which are useful? Br J Clin Pharmacol. 2017;83(4):777-790. doi:10.1111/bcp.13160
Duffull SB, Wright DF, Winter HR. Interpreting population pharmacokinetic-pharmacodynamic analyses-a clinical viewpoint. Br J Clin Pharmacol. 2011;71(6):807-814. doi:10.1111/j.1365-2125.2010.03891.x
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(11):6454-6461. doi:10.1128/AAC.03620-14
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(9):927-934. doi:10.1177/009127000104100901
Jacqz-Aigrain E, Leroux S, Thomson AH, et al. Population pharmacokinetic meta-analysis of individual data to design the first randomized efficacy trial of vancomycin in neonates and young infants. J Antimicrob Chemother. 2019;74(8):2128-2138. doi:10.1093/jac/dkz158
UpToDate. Vancomycin: pediatric drug information. Dosing: neonatal. 2023. Accessed October 8, 2023. https://www.uptodate.com/contents/vancomycin-pediatric-drug-information?sectionName=Neonatal&topicId=12874&search=vancomycine&usage_type=panel&anchor=F53462617&source=panel_search_result&selectedTitle=2~148&showDrugLabel=true&kp_tab=drug_pediatric&display_rank=1#F53462617
Hikma Farmaceutica (Portugal) S.A. Vancomycin. Summary of product characteristics. 2023. Accessed October 8, 2023. https://www.geneesmiddeleninformatiebank.nl/smpc/h110475_smpc.pdf
Hill LF, Clements MN, Turner MA, et al. Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial. Lancet Child Adolesc Health. 2022;6(1):49-59. doi:10.1016/S2352-4642(21)00305-9
EUCAST. MIC distributions for Staphylococcus aureus MRSA. Accessed October 8, 2023. https://mic.eucast.org/search/?search%5Bmethod%5D=mic&search%5Bantibiotic%5D=-1&search%5Bspecies%5D=452&search%5Bdisk_content%5D=-1&search%5Blimit%5D=50
Alexander SPH, Kelly E, Mathie A, et al. THE CONCISE GUIDE TO PHARMACOLOGY 2019/20: Introduction and Other Protein Targets. Br J Pharmacol. 2018;176(S1). Portico. https://doi.org/10.1111/bph.14747
Sinha J, Al-Sallami HS, Duffull SB. Choosing the allometric exponent in covariate model building. Clin Pharmacokinet. 2019;58(1):89-100. doi:10.1007/s40262-018-0667-0
Leys K, Stroe MS, Annaert P, et al. Pharmacokinetics during therapeutic hypothermia in neonates: from pathophysiology to translational knowledge and physiologically-based pharmacokinetic (PBPK) modeling. Expert Opin Drug Metab Toxicol. 2023;19(7):461-477. doi:10.1080/17425255.2023.2237412
LaRosa DA, Ellery SJ, Walker DW, Dickinson H. Understanding the full spectrum of organ injury following intrapartum asphyxia. Front Pediatr. 2017;5:16. doi:10.3389/fped.2017.00016
Sehgal A, Linduska N, Huynh C. Cardiac adaptation in asphyxiated infants treated with therapeutic hypothermia. J Neonatal Perinatal Med. 2019;12(2):117-125. doi:10.3233/NPM-1853
Keles E, Wintermark P, Groenendaal F, et al. Serum creatinine patterns in neonates treated with therapeutic hypothermia for neonatal encephalopathy. Neonatology. 2022;119(6):686-694. doi:10.1159/000525574
Robertsson Grossmann K, Bárány P, Blennow M, Chromek M. Acute kidney injury in infants with hypothermia-treated hypoxic-ischaemic encephalopathy: an observational population-based study. Acta Paediatr. 2022;111(1):86-92. doi:10.1111/apa.16078
Borloo N, Smits A, Thewissen L, Annaert P, Allegaert K. Creatinine trends and patterns in neonates undergoing whole body hypothermia: a systematic review. Children (Basel). 2021;8(6):475. doi:10.3390/children8060475
van Wincoop M, de Bijl-Marcus K, Lilien M, van den Hoogen A, Groenendaal F. Effect of therapeutic hypothermia on renal and myocardial function in asphyxiated (near) term neonates: a systematic review and meta-analysis. PLoS ONE. 2021;16(2):e0247403. doi:10.1371/journal.pone.0247403
Favié LMA, de Haan TR, Bijleveld YA, et al. Prediction of drug exposure in critically ill encephalopathic neonates treated with therapeutic hypothermia based on a pooled population pharmacokinetic analysis of seven drugs and five metabolites. Clin Pharmacol Ther. 2020;108(5):1098-1106. doi:10.1002/cpt.1917
Bijleveld YA, de Haan TR, van der Lee JH, et al. Evaluation of a system-specific function to describe the pharmacokinetics of benzylpenicillin in term neonates undergoing moderate hypothermia. Antimicrob Agents Chemother. 2018;62(4):e02311-17. doi:10.1128/AAC.02311-17
Bijleveld YA, Mathôt R, van der Lee JH, et al. Population pharmacokinetics of amoxicillin in term neonates undergoing moderate hypothermia. Clin Pharmacol Ther. 2018;103(3):458-467. doi:10.1002/cpt.748
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(1):75-84. doi:10.1111/j.1365-2125.2006.02725.x
Go H, Momoi N, Kashiwabara N, et al. Neonatal and maternal serum creatinine levels during the early postnatal period in preterm and term infants. PLoS ONE. 2018;13(5):e0196721. doi:10.1371/journal.pone.0196721
Vandendriessche A, Allegaert K, Cossey V, Naulaers G, Saegeman V, Smits A. Prospective validation of neonatal vancomycin dosing regimens is urgently needed. Curr Ther Res Clin Exp. 2014;76:51-57. doi:10.1016/j.curtheres.2014.06.001
Aljutayli A, El-Haffaf I, Marsot A, Nekka F. An update on population pharmacokinetic analyses of vancomycin, part II: in pediatric patients. Clin Pharmacokinet. 2022;61(1):47-70. doi:10.1007/s40262-021-01050-w