Tuesday, 24 May 2022

Publications

An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial

Authors: Hill LF, Turner MA, Lutsar I, et al; NeoVanc Consortium.
Published in: Trials. 2020;21(1):329

Background Vancomycin has been used in clinical practice for over 50 years; however, validated, pharmacokinetic (PK) data relating clinical outcomes to different dosing regimens in neonates are lacking. Coagulase negative staphylococci (CoNS) are the most commonly isolated organisms in neonatal,…

Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial

This article features the findings of NeoVanc, the largest neonatal vancomycin efficacy trial ever conducted: • No clear benefit was seen with the use of an optimised short (5±1 day) course of vancomycin, including a loading dose, compared to a longer (10±2 day) standard course in babies treated…

Pharmacodynamics of vancomycin for CoNS infection: experimental basis for optimal use of vancomycin in neonates.

Authors: Ramos-Martín V, Johnson A, Livermore J et al; NeoVanc Consortium.
Published in: J Antimicrob Chemother. 2016 Apr;71(4):992-1002

OBJECTIVES CoNS are the most common cause of neonatal late-onset sepsis. Information on the vancomycin pharmacokinetics/pharmacodynamics against CoNS is limited. The aim of this study was to characterize vancomycin pharmacokinetic/pharmacodynamic relationships for CoNS and investigate neonatal…

Population pharmacokinetic meta-analysis of individual data to design the first randomized efficacy trial of vancomycin in neonates and young infants

Authors: Jacqz-Aigrain E, Leroux S, Thomson AH, et al
Published in: J Antimicrob Chemother. 2019 Aug 1;74(8):2128-2138

Objectives: In the absence of consensus, the present meta-analysis was performed to determine an optimal dosing regimen of vancomycin for neonates. Methods: A 'meta-model' with 4894 concentrations from 1631 neonates was built using NONMEM, and Monte Carlo simulations were performed to design an…

Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial

Authors: Hill L.F, Clements M.N, Turner M.A, et al on behalf of the NeoVanc Consortium
Published in: The Lancet. doi.org/10.1016/S2352-4642(21)00305-9

Background Vancomycin is the most widely used antibiotic for neonatal Gram-positive sepsis, but clinical outcome data of dosing strategies are scarce. The NeoVanc programme comprised extensive preclinical studies to inform a randomised controlled trial to assess optimised vancomycin dosing. We…

An optimised dosing regimen vs. a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in infants less than 90 days: the NeoVanc tria

Authors: Louise F Hill, Mark A Turner, et al on behalf of the NeoVanc Consortium
Published in: Trials 21, 329 (2020)

Background Vancomycin has been used in clinical practice for over 50 years; however, validated, pharmacokinetic (PK) data relating clinical outcomes to different dosing regimens in neonates are lacking. Coagulase negative staphylococci (CoNS) are the most commonly isolated organisms in neonatal,…

Interim pharmacokinetic analysis of a multi-centre randomised open label phase IIb study in neonates to validate the meta-analysis population pharmacokinetic model used to simulate an optimised dosing regimen in neonates and infants aged < 90 days: the NeoVanc trial

Authors: L. Hill, E. Jacqz-Aigrain, V. Elie et al on behalf of the NeoVanc Consortium
Presented at: ECCMID

Background: Vancomycin remains one of the most widely prescribed antibiotics for Gram-positive neonatal late onset sepsis (LOS), however, a consensus on optimal vancomycin dosing and duration is lacking. Robust neonatal clinical pharmacokinetic (PK) data comparing different vancomycin dosing…

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This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no: 602041
Call: FP7-HEALTH-2013-INNOVATION-1
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