Tuesday, 24 May 2022

27 November 2021

New study finds no clear benefit from a shorter optimised vancomycin treatment in babies with Gram positive late onset sepsis

PRESS RELEASE

NeoVanc, a European trial featured in The Lancet Child & Adolescent Health, has published the findings of 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

NeoVanc was a European, multicentre research study coordinated by Penta and funded by the European Commission’s 7th Framework Programme. It compared the efficacy, safety and pharmacokinetics of an optimised dosing regimen with a standard dosing regimen of vancomycin in infants with late onset sepsis. NeoVanc took place between March 2017 and July 2019 and involved 242 infants from 22 neonatal intensive care units in Italy, Greece, Estonia, Spain and the UK. The aim of the study was to compare recovery from sepsis as well as relapses or new infections requiring further treatment between the two groups.

Dr Louise Hill, Lecturer in Paediatric Infectious Diseases at St George’s, University of London said, “Neonatal sepsis is a global health priority with around 3 million cases per year worldwide. Premature babies and infants in the first 3 months of life represent a particularly vulnerable group because their immune systems are not yet fully developed. In Europe, coagulase-negative staphylococci (CoNS) are the most frequently identified bacteria in neonatal late onset sepsis and vancomycin is the antibiotic most commonly used to treat them. However, despite being used for over 50 years, there are very few studies comparing different dosing regimens of vancomycin.”

To bridge this gap, the NeoVanc programme* set out to compare the efficacy of administering an optimised regimen with a first (loading) dose of 25 mg/kg of vancomycin followed by lower daily dosing (15 mg/kg, interval determined by postmenstrual age (PMA)) over a shorter 5-day course with a standard 10-day course with lower daily dosing throughout (15 mg/kg, interval determined by PMA).

According to the Chief Investigator, Professor Mike Sharland of the Paediatric Infectious Diseases Research Group at St George’s, University of London, “the results of the study show that there is no clear advantage for adopting a shorter 5-day course, with a loading dose, over the standard 10-day course in infants under 3 months of age with severe sepsis. A NeoVanc follow-up study is planned to collect long-term hearing data on those infants who were affected by hearing dysfunction, particularly in relation to the use of the shorter treatment course.”

Padua – Italy, 27 November 2021



About the article
The article is: Optimised versus standard dosing of vancomycin in infants with Gram-positive sepsis (NeoVanc): a multicentre, randomised, open-label, phase 2b, non-inferiority trial
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
https://doi.org/10.1016/S2352-4642(21)00305-9
http://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00305-9/fulltext

*About NeoVanc

The NeoVanc project set out to analyse the adaptability of an off-label medicine, vancomycin, to the specific needs of neonates and infants, by developing an optimal dosing regimen. Coordinated by Penta, NeoVanc has successfully recruited almost 250 participants, and involved more than 20 sites in 5 European countries. This randomised, open label, phase IIb study compares the efficacy, safety and pharmacokinetics of an optimised dosing regimen with a standard dosing regimen of vancomycin in neonates and infants with late onset bacterial sepsis. The study team is currently developing publications to present the results to the wider public.
The NeoVanc project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no: 602041.


List of investigators and participating centres:
● Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George’s, University of London, London, UK (L F Hill MBChB, Prof P T Heath FRCPCH, Prof M Sharland MD);
● The Medical Research Council Clinical Trials Unit, University College London, London, UK (M N Clements PhD, Prof A S Walker PhD);
● Institute of Translational Medicine, University of Liverpool, Liverpool, UK (Prof M A Turner PhD);
● Division of Pediatric Infectious Diseases, Department of Women’s and Children’s Health, University of Padova, Padova, Italy (D Donà PhD);
● Fondazione Penta, Padua, Italy (D Donà);
● University of Tartu, Tartu, Estonia (Prof I Lutsar PhD);
● Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, Paris, France (Prof E Jacqz-Aigrain PhD);
● 3rd Department of Pediatrics, Aristotle University, Thessaloniki, Greece (Prof E Roilides PhD);
Therakind, London, UK (L Rawcliffe MBA);
● Hospital Universitario 12 de Octubre, Madrid, Spain (C Alonso-Diaz PhD);
● Azienda Ospedale-Universita’ di Padova, Fondazione Istituto di Ricerca Pediatrica, Padova, Italy (Prof E Baraldi MD);
● Ospedale Pediatrico Bambino Gesù, Rome, Italy (A Dotta MD)


About Penta
Penta is an international independent research network dedicated to scientific research in favour of children’s health. It was born in 1991 as a European network for the treatment of paediatric HIV, with the aim of undertaking independent clinical trials on antiretroviral therapies for children with HIV. To-date, the Penta portfolio of studies includes other paediatric infectious diseases, such as hepatitis, tuberculosis, fungal diseases, sepsis as well as infections in pregnancy and emerging or neglected childhood infections. Through our work, which is the result of collaborations between medical professionals and researchers in more than 110 centres in 31 countries around the world, we have brought infectious diseases and the issue of antimicrobial resistance to the fore as they are key determinants of public health globally.
We are people united by a common vision, that of improving the quality of life of mothers and children, by preventing and treating infectious childhood diseases. Through our passion for research, we carry out important advocacy activities towards the right to health of children wherever they live.
For more information on Penta visit our website: www.penta-id.org
or write to:
Francesca Mazzetto – Head of the Communication Office of the Penta ONLUS Foundation
Email: francesca.mazzetto@pentafoundation.org
Phone: +39 348 6151202

About St George’s, University of London
St George’s, University of London is the UK’s specialist health university. We are shaping modern health with transformative research, expert teaching and hands-on learning.
Our three research institutes focus on biomedical and scientific discovery, advancing the prevention and treatment of disease in the fields of population health, heart disease and infection - three of the greatest challenges to global health in the 21st century.
We provide a world-class multi-professional health sciences education that equips our graduates to meet today’s healthcare needs through relevant scientific research, clinical excellence, strong interpersonal skills and team-based working. Sharing a clinical environment with a major London teaching hospital, our innovative approach to education results in well-rounded, highly skilled clinicians, scientists, and health and social care professionals.

This Press Release reflects only the author’s views and the European Union is not liable for any use that may be made of the information contained therein.

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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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