Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): A randomised controlled trial.

Summary

NeoMero-1 was a multicentre, open-label phase III randomised superiority trial across 18 neonatal units in six countries comparing meropenem with standard-of-care regimens (ampicillin plus gentamicin or cefotaxime plus gentamicin) for empirical treatment of neonatal late onset sepsis. It enrolled infants with culture-confirmed or clinically suspected sepsis, assessing treatment success at test-of-cure, safety, mortality and acquisition of carbapenem-resistant Gram-negative organisms. The trial was underpowered and found no evidence that meropenem was superior overall, though outcomes favoured meropenem in culture-positive infants. The authors suggest reserving meropenem for neonates more likely to have Gram-negative sepsis, particularly where ESBL- and AmpC-producing organisms circulate.

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