Equivalence trials for sepsis in newborns and young infants

Overview

Serious bacterial infections are a major cause of neonatal and young-infant deaths worldwide. Identification is difficult, andstandard-of-care treatment is demanding. Several trials have examined simplified treatment regimes that include oral antibiotics.In this report, four recently published randomized trials were analysed for their statistical power to demonstrate equivalence ofsimplified antibiotic regimens with the standard of care among children with bacterial infection. These trials were found to beunderpowered in terms of both overall sample size and number of included children with bacterial infection. They cannot supportthe conclusion that the alternative antibiotic regimens studied are equally effective. Much larger sample sizes and more selectiveinclusion criteria are needed. The conclusion that simpler treatment regimens for the treatment of newborn sepsis are effective isnot warranted, based on the published trials. The promotion of such regimens as an alternative to established treatments needsto be stopped.