Study design

Design: Randomised open-label, non-inferiority trial.

Study question

Setting: Multicentre including 17 teaching hospitals in the Netherlands between February 2018 and May 2021.

Patients: 510 infants were included in the study. Inclusion criteria were greater than 35 weeks’ gestation at birth, with weight of at least 2 kg, who were intended to receive a 7-day course of antibiotics for probable bacterial infection. Infants were recruited at postnatal age between 0 day and 28 days.

Probable bacterial infection was defined as the presence of maternal risk factors or clinical symptoms and elevated inflammatory parameters (C reactive protein ≥10 mg/L or elevated procalcitonin concentrations according to the postnatal age-related nomogram) despite blood culture negativity.

253 neonates were assigned to receive oral amoxicillin–clavulanic acid as the intervention group, and 253 neonates continued intravenous antibiotics as the control group.

Intervention: Neonates were randomly assigned (1:1) to the intervention group (switch to oral antibiotics after 48–72 hours) or the control group (continuation on intravenous antibiotics). Both groups were treated for 7 days in total.

Outcomes: The primary outcome was cumulative bacterial reinfection within 28 days after treatment completion, …