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

Bijleveld, Yuma A.; Haan, Timo de; Toersche, Jan; Jorjani, Sona; Lee, Johanna van der; Groenendaal, Floris; Dijk, Peter H.; Heijst, Arno van; Gavilanes, Antonio W. D.; Jonge, Rogier de; Dijkman, Koen P.; Straaten, Henrica van; Rijken, Monique; Zonnenberg, Inge A.; Cools, Filip; Nuytemans, Debbie H. G. M.; Mathôt, Ron A. A.

doi:10.1016/j.jchromb.2014.01.035

Cited by 69 publications

(61 citation statements)

References 59 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Dilution of the supernatant with water or a mobile phase before injection into the LC system is often reported. However, direct injection of the supernatant after the centrifugation step was also published .…”

Section: Sample Pre‐treatmentmentioning

confidence: 99%

Modern methods for vancomycin determination in biological fluids by methods based on high‐performance liquid chromatography – A review

Javorská

Krcmova

Solichová

et al. 2015

J of Separation Science

View full text Add to dashboard Cite

Vancomycin is a glycopeptide antibiotic used in the therapy of severe bacterial infection. The monitoring of vancomycin levels is recommended because of its narrow therapeutic index and toxicity. This measurement is especially appropriate in patients with unstable renal functions, who receive high doses of vancomycin or present serious bacterial infections accompanied by important sequestration of liquids when it could be difficult to achieve the optimal therapeutic dose. Most of the methods for vancomycin determination in routine practice are immunoassays. However, chromatography-based techniques in combination with UV or mass spectrometry detection provide results with greater accuracy and precision also in complicated biological matrices. This review provides a detailed overview of modern approaches for the chromatographic separation of vancomycin in various biological samples and useful sample preparation procedures for vancomycin determination in various biological fluids.

show abstract

Section: Sample Pre‐treatmentmentioning

confidence: 99%

Modern methods for vancomycin determination in biological fluids by methods based on high‐performance liquid chromatography – A review

Javorská

Krcmova

Solichová

et al. 2015

J of Separation Science

View full text Add to dashboard Cite

show abstract

“…From the above, it is evident that the number of blood samples collected in the clinical pharmacology study is as critical as the number of patients available and the dose levels under consideration for the study . Tools have been developed in statistical research to provide insight into the contribution of (individual) input data to the overall precision of parameter estimates . These techniques can become powerful when combined with new sampling techniques such as dried blood spots or microsampling, particularly in special paediatric patient groups such as neonates.…”

Section: Introductionmentioning

confidence: 99%

How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians*

Vermeulen

Anker

Pasqua

et al. 2016

Journal of Pharmacy and Pharmacology

View full text Add to dashboard Cite

ObjectivesIn children, there is often lack of sufficient information concerning the pharmacokinetics (PK) and pharmacodynamics (PD) of a study drug to support dose selection and effective evaluation of efficacy in a randomised clinical trial (RCT). Therefore, one should consider the relevance of relatively small PKPD studies, which can provide the appropriate data to optimise the design of an RCT.MethodsBased on the experience of experts collaborating in the EU‐funded Global Research in Paediatrics consortium, we aimed to inform clinician‐scientists working with children on the design of investigator‐initiated PKPD studies.Key findingsThe importance of the identification of an optimal dose for the paediatric population is explained, followed by the differences and similarities of dose‐ranging and efficacy studies. The input of clinical pharmacologists with modelling expertise is essential for an efficient dose‐finding study.ConclusionsThe emergence of new laboratory techniques and statistical tools allows for the collection and analysis of sparse and unbalanced data, enabling the implementation of (observational) PKPD studies in the paediatric clinic. Understanding of the principles and methods discussed in this study is essential to improve the quality of paediatric PKPD investigations, and to prevent the conduct of paediatric RCTs that fail because of inadequate dosing.

show abstract

“…However, careful choice of sample preparation method and internal standard, and validation of assays, should be able to avoid the majority of pitfalls 33 . Bijleveld et al 36 recently reported that LC-MS/MS documented slightly lower vancomycin concentrations than Fluorescence Polarization Immunoassay. However, the applicability of their LC-MS/MS was only tested in 3 neonatal patients 36 .…”

Section: Discussionmentioning

confidence: 99%

Prospective validation of neonatal vancomycin dosing regimens is urgently needed

Vandendriessche

Allegaert

Cossey

et al. 2014

Current Therapeutic Research

View full text Add to dashboard Cite

BackgroundAlthough vancomycin is frequently used to treat neonatal late-onset sepsis, there is no consensus on the optimal dosing regimen. Because many neonates needed dosing adaptation due to suboptimal trough values, the vancomycin dosing regimen in our neonatal department was changed during 2012.ObjectiveWe aimed to document the need for validation of neonatal vancomycin dosing by exploring serum trough levels achieved using 2 published dosing regimens (previous regimen: based on postmenstrual age and serum creatinine and new regimen: based on postmenstrual age and postnatal age) and to identify covariates associated with suboptimal vancomycin trough levels (<10 mg/L).MethodsRoutine therapeutic drug monitoring serum trough levels quantified after initiation of intravenous vancomycin therapy and clinical covariates were retrospectively collected. Median vancomycin trough levels of both dosing regimens were compared using the Mann-Whitney U test. The influence of continuous and dichotomous covariates on achieving a suboptimal trough level was explored using the Van Elteren test (stratified Mann-Whitney U test) and Mantel-Haenszel test (stratified χ2 test), respectively. Covariates significant in monovariate analysis were subsequently included in a logistic regression analysis.ResultsIn total, 294 observations (median current weight 1870 g [range = 420–4863 g] and median postmenstrual age 35.07 weeks [range = 25.14–56.00 weeks]) were included. Using the previous and new dosing regimens, 66.3% and 76.2% of trough levels, respectively, were below 10 mg/L. Overall, suboptimal vancomycin trough values were significantly associated with lower weight (birth weight and current weight) and age (gestational age and postmenstrual age).ConclusionsThe majority of vancomycin trough levels in neonates achieved using 2 published dosing regimens did not reach the target of 10 mg/L. This illustrates the urgent need for prospective validation of neonatal vancomycin dosing regimens. We anticipate that dosing regimens integrating covariates reflecting general physiological maturation and renal maturation, as well as disease characteristics, could improve vancomycin exposure in neonates.

show abstract

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

Cited by 69 publications

References 59 publications

Modern methods for vancomycin determination in biological fluids by methods based on high‐performance liquid chromatography – A review

Modern methods for vancomycin determination in biological fluids by methods based on high‐performance liquid chromatography – A review

How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians*

Prospective validation of neonatal vancomycin dosing regimens is urgently needed

Contact Info

Product

Resources

About