Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial.

Trials
Irja LutsarNeoMero Consortium

Abstract

Late onset neonatal sepsis (LOS) with the mortality of 17 to 27% is still a serious disease. Meropenem is an antibiotic with wide antibacterial coverage. The advantage of it over standard of care could be its wider antibacterial coverage and thus the use of mono-instead of combination therapy. NeoMero-1, an open label, randomised, comparator controlled, superiority trial aims to compare the efficacy of meropenem with a predefined standard of care (ampicillin + gentamicin or cefotaxime + gentamicin) in the treatment of LOS in neonates and infants aged less than 90 days admitted to a neonatal intensive care unit.A total of 550 subjects will be recruited following a 1:1 randomisation scheme. The trial includes patients with culture confirmed (at least one positive culture from normally sterile site except coagulase negative staphylococci in addition to one clinical or laboratory criterion) or clinical sepsis (at least two laboratory and two clinical criteria suggestive of LOS in subjects with postmenstrual age < 44 weeks or fulfilment of criteria established by the International Pediatric Sepsis Consensus Conference in subjects with postmenstrual age ≥ 44 weeks). Meropenem will be given at a dose of 20 mg/kg q12h or q8h depending ...Continue Reading

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Citations

Aug 2, 2013·The Journal of Antimicrobial Chemotherapy·Clarissa OeserMike Sharland
Jun 27, 2012·Antimicrobial Agents and Chemotherapy·Helgi PadariIrja Lutsar
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Aug 2, 2017·Future Microbiology·Nazario D Rivera-ChaparroRachel G Greenberg
Apr 24, 2018·The Journal of Antimicrobial Chemotherapy·Eva GermovsekUNKNOWN NeoMero Consortium

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Methods Mentioned

BETA
PCRs

Software Mentioned

PopPK
NeoMero
NQuery

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