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Neonates are susceptible for bacterial infections. In case of probable infection (negative cultures but elevated inflammatory parameters and/or clinical symptoms), intravenous (IV) antimicrobial treatment is usually administered for 7 days. In older children, IV antibiotics are often switched to oral antibiotics after clinical improvement. Neonatal oral antibiotics seem a promising therapy based on a few published studies, but firm evidence on the equivalent effectiveness and safety is absent. Therefore, a large randomised controlled study needs to be performed. When intravenous-to-oral antibiotic switch therapy in neonatal infections is considered safe and effective, it can have huge effects on the quality of life, admission days and costly in-hospital resource use. The objectives of this research project are:

1. To demonstrate non-inferiority of intravenous-to-oral antibiotic switch therapy in clinically stable neonates with probable bacterial infection compared to a complete course of intravenous antibiotic therapy

2. To describe the pharmacokinetics of oral amoxicillin/clavulanic acid in neonates

3. To quantify the cost-effectiveness of oral antimicrobial switch therapy in neonates

This non-inferiority RCT includes 2 x 290 neonates (0-28 days, GA > 35 weeks; > 2 kg) with probable bacterial infection. These neonates initiate with empiric intravenous antibiotics for 48 hours, whereafter eligible neonates will be randomised to continue with intravenous antibiotics or to switch to oral antibiotics (amoxicillin/clavulanic acid), total treatment duration 7 days. For the first 30 neonates in the oral switch group, a detailed PK profile will be constructed. Participants will be followed closely by an online diary, phone calls and OPD visit. The primary outcome is bacterial re-infection within 28 days after finishing treatment. Secondary outcomes are hospitalization duration, costs, pharmacokinetic profile of oral amoxicillin, quality of life, side effects.

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