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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

Crossref DOI link: https://doi.org/10.1186/s13063-020-4184-8

Published Online: 2020-04-15

Published Print: 2020-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

,

Hill, Louise F. https://orcid.org/0000-0001-9912-3593
Turner, Mark A.

Lutsar, Irja

Heath, Paul T.

Hardy, Pollyanna

Linsell, Louise

Jacqz-Aigrain, Evelyne

Roilides, Emmanuel

Sharland, Mike
Funding

Funding for this research was provided by:

FP7 Health (602041)
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Article History

Received: 13 July 2019

Accepted: 19 February 2020

First Online: 15 April 2020

Ethics approval and consent to participate

: The trial received a favourable opinion from the London - West London & GTAC Research Ethics Committee (REC reference: []/LO/1026) on 18 July 2016. Ethics Committee approvals have also been granted in Estonia, Greece, Italy and Spain, as well as Regulatory Body approvals in each country.Any modifications/updates to trial documents will be communicated to trial personnel and study sites following the necessary ethical and regulatory approvals.Written consent has been gained from all participant’s parents/guardians by trained research personnel; parents/guardians are free to withdraw their babies at any time.Trials insurance is in place.

: Not applicable.

: The authors declare that they have no competing interests.

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