Monday, 30 January 2023

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 for sepsis occurring in hospital, also called late onset sepsis
• Babies in the short course group were more commonly assessed as not fully recovered by the end of treatment as compared with babies in the long course group
• Twice as many babies (30%) in the short course group failed routine hearing testing compared to the longer course (15%); long-term hearing data are currently being collected
• Kidney problems were rare and comparable between the two groups
• Four out of ten babies in the trial had a positive blood culture at the time of enrolment, which is high, and shows that the babies in the study had serious infections

Louise F Hill*, Michelle N Clements*, Mark A Turner, Daniele Donà, Irja Lutsar, Evelyne Jacqz-Aigrain, Paul T Heath, Emmanuel Roilides, Louise Rawcliffe, Clara Alonso-Diaz, Eugenio Baraldi, Andrea Dotta, Mari-Liis Ilmoja, Ajit Mahaveer, Tuuli Metsvaht, George Mitsiakos, Vassiliki Papaevangelou, Kosmas Sarafidis, A Sarah Walker, Michael Sharland, on behalf of the NeoVanc Consortium†

The Lancet Child & Adolescent Health 2021; published Online Nov 26


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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
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