Vancomycin is the critically important antibiotic to treat neonatal Late Onset Sepsis (LOS) due to Gram positive bacteria in neonates but these organisms also create biofilms which are extremely resistant to antibiotics and a standardised dosing regimen for premature infants has not yet been defined. NeoVanc compared the efficacy of an optimised regimen to a standard regimen in infants with late onset sepsis that was known or suspected to be caused by Gram-positive microorganisms.
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Treatment of late onset bacterial sepsis caused by vancomycin susceptible bacteria in neonates and infants aged under three months
NeoVanc was a multi-centre randomised open label phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged at least 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms. NeoVanc involved 12 European partners and was coordinated by Penta.
There are different antibiotics used to treat infections in infants; however, not many studies have been done in babies to see which antibiotics work best. The NeoVanc project investigated the most effective way of administering Vancomycin to children.
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. NeoVanc compared infant recovery from sepsis as well as relapses or new infections.
NeoVanc was the largest neonatal vancomycin efficacy trial ever conducted and recruited 242 babies across 22 neonatal units in 5 European countries (Estonia, Greece, Italy, Spain and the UK) between March 2017 and December 2019. The trial compared an optimised, 5-day dosing regimen (which included a loading dose) to a standard 10-day dosing regimen (with no loading dose). The trial did not identify any benefit in reducing the treatment course from 10 days to 5 days i.e. adopting the optimised regimen. Furthermore, twice as many babies (30%) in the optimised, short course group failed routine hearing screening compared to the longer, standard course (15%) although not all babies had a hearing test performed.
A NeoVanc long-term follow up study is underway to further investigate this potential hearing signal and evaluate hearing outcomes in babies recruited to the trial. The results of the NeoVanc trial emphasise the importance of ensuring adequately powered trials to identify potential toxicity signals in this population.
This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no: 602041.