Evidence · Randomised trial
Randomised controlled trial of fosfomycin in neonatal sepsis: pharmacokinetics and safety in relation to sodium overload.
- Early-onset sepsis
- Fluids and electrolytes
- Infection
- Late-onset sepsis
- Medical
- Metabolic, endocrine and renal
Summary
Single-centre open-label randomised controlled trial in Kilifi, Kenya, of 120 neonates with clinical sepsis receiving ampicillin and gentamicin, with half also given intravenous then oral fosfomycin. It assessed serum sodium, adverse events and fosfomycin pharmacokinetics over 28 days of follow-up. No evidence of an effect on sodium or gastrointestinal side effects was found, and pharmacokinetic modelling informed age-related dosing. The authors suggest fosfomycin as a potentially affordable combination option for neonatal sepsis in low-resource settings, needing larger safety studies including very preterm and critically ill infants.
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- Licence:
- Open (Creative Commons)
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