Authors
1
Children Welfare Teaching Hospital, Medical City, Bab Al-Muadham, Baghdad, Iraq
2
Children Welfare Teaching Hospital, Medical City, Bab Al-Muadham, Baghdad, Iraq.
3
Department of Pharmacology, College of Pharmacy, Al-Nahrain University, Baghdad, Iraq.
,
Document Type : Research Paper
Abstract
Background: Due to the increasing resistance of staphylococcal strains, vancomycin is often used as empiric therapy in neonatal late-onset sepsis. The Infectious Disease Society of America 2011 methicillin-resistant Staphylococcus aureus guidelines recommended that vancomycin's goal serum trough level concentration be increased from 5-10 mg/L to 10 to 20 mg/L in children and adults. Neonatal references have also recommended these target levels but dosing recommendations remained the same as previous. Aim: assessment of the percentage of neonates attaining a serum trough level between 10 and 20 mg/L with empiric vancomycin dosing in neonatal care unit patients and the evaluation of clinical outcomes and adverse drug events in relation to initial trough level. Patients and methods: A prospective cohort study was conducted in the neonatal care unit of Children Welfare Teaching Hospital of Medical City on 43 patients (neonates) during the period from 27th of January 2020 through 15th of December 2020. Patients included were treated with vancomycin and received a minimum of three doses. Results: Of the 43 vancomycin serum trough levels included in the primary outcome, only 14 (32.6%) achieved a goal trough of 10 to 20 mg/L with empiric dosing. Overall, vancomycin trough values below 10 mg/L were significantly associated with lower gestational age (<37 weeks) (P value 0.0394). No statistically significant difference between the group of patients who achieved a trough of greater Than 10 mg/L and those who did not in terms of hospital stay and mortality Conclusion: The initial vancomycin dosing regimens result in low attainment of vancomycin trough levels between 10–20 mg/L in neonates. However, the trough level does not predict mortality or clinical outcomes in patients with culture-confirmed late-onset sepsis.
- Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, et al. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002;110:285-91.
- Sánchez PJ, Moallem M, Cantey JB, Milton A, Michelow IC. Empiric therapy with vancomycin in the neonatal intensive care unit: let's" get smart" globally! Jornal de Pediatria. 2016;92:432-35.
- 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: executive summary. Clin Infect Dis. 2011;52:285-92.
- Ringenberg T, Robinson C, Meyers R, Degnan L, Shah P, Siu A, et al. Achievement of Therapeutic Vancomycin Trough Serum Concentrations with Empiric Dosing in Neonatal Intensive Care Unit Patients. The Pediatric infectious disease journal. 2015;34:742-47.
- Vandendriessche A, Allegaert K, Cossey V, Naulaers G, Saegeman V, Smits A. Prospective validation of neonatal vancomycin dosing regimens is urgently needed. Current therapeutic research, clinical and experimental. 2014;76:51-57.
- Abouelkheir M, Almohaizeie A, Almutairi A, Almuhisen S, Alqahtani S, Alsultan A. Evaluation of vancomycin individualized model-based dosing approach in neonates. Pediatrics & Neonatology. 2023;64:327-34.
- de Hoog M, Mouton JW, van den Anker JN. Vancomycin: pharmacokinetics and administration regimens in neonates. Clinical pharmacokinetics. 2004;43:417-40.
- Martin RJ, Fanaroff AA, Walsh MC, eds. Fanaroff and Martin's Neonatal-Perinatal Medicine. 10th ed. Philadelphia: Elsevier Saunders; 2015.
- Bauer LA. Applied Clinical Pharmacokinetics. 3rd ed. New York (NY): McGraw-Hill Education; 2014.
- Alsultan A, Al Munjem MF, Atiq KM, Aljehani ZK, Al Muqati H, Almohaizeie A, et al. Population pharmacokinetics of vancomycin in very low birth weight neonates. Frontiers in Pediatrics. 2023;11:1093171.
- De Rose DU, Cairoli S, Dionisi M, Santisi A, Massenzi L, Goffredo BM, et al. Therapeutic drug monitoring is a feasible tool to personalize drug administration in neonates using new techniques: an overview on the pharmacokinetics and pharmacodynamics in neonatal Age. Int J Mol Sci. 2020 Aug 17;21(:5898.
- Tozer TN, Rowland M. Introduction to Pharmacokinetics and Pharmacodynamics: The Quantitative Basis of Drug Therapy. Philadelphia: Lippincott Williams & Wilkins; 2006.
- Ywaya R, Newby B. Assessment of Empiric Vancomycin Regimen in the Neonatal Intensive Care Unit. The Canadian journal of hospital pharmacy. 2019;72:211-18.
- Kahl L, Hughes HK. The Harriet Lane Handbook. 21st ed. Philadelphia: Elsevier Health Sciences; 2017.
- Paediatric Formulary Committee. BNF for Children 2019-2020. London: BMJ, Pharmaceutical Press, and RCPCH Publications; 2019.
- Bradley JS, Nelson JD, Barnett E, Cantey JB, Kimberlin DW, Palumbo PE, et al. Nelson’s Pediatric Antimicrobial Therapy. 26th ed. Itasca (IL): American Academy of Pediatrics; 2020.
- AAP Committee on Infectious Diseases, Kimberlin DW, Brady MT, Jackson MA, editors. Red Book: Report of the Committee on Infectious Diseases. 31st ed. Itasca (IL): American Academy of Pediatrics; 2018.
- Dawoud TH, Khan N, Afzal U, Varghese N, Rahmani A, Abu-Sa'da O. Assessment of initial vancomycin trough levels and risk factors of vancomycin-induced nephrotoxicity in neonates. European Journal of Hospital Pharmacy. 2020:ejhpharm-2019-002181.
- Dersch-Mills D, Bengry T, Akierman A, Alshaikh B, Yusuf K. Assessment of initial vancomycin dosing in neonates. Paediatrics & child health. 2014;19:e30-4.
- Allegaert K, Verbesselt R, Naulaers G, van den Anker JN, Rayyan M, Debeer A, et al. Developmental Pharmacology: Neonates are not just small adult. Acta Clinica Belgica. 2008;63:16-24.
- Pacifici GM, Allegaert K. Clinical pharmacokinetics of vancomycin in the neonate: a review. Clinics. 2012;67:831-37.
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