Abstract
BackgroundWorldwide many neonates suffer from bacterial infections. Adequate treatment is important but is associated with prolonged hospitalization for intravenous administration. In older children, oral switch therapy has been proven effective and safe for several indications and is now standard care.ObjectivesTo evaluate the currently available evidence on pharmacokinetics, safety and efficacy of oral antibiotics and oral switch therapy in neonates (0–28 days old).MethodsWe performed systematic searches in Medline, Embase.com, Cochrane, Google Scholar and Web of Science. Studies were eligible if they described the use of oral antibiotics in neonates (0–28 days old), including antibiotic switch studies and pharmacological studies.ResultsThirty-one studies met the inclusion criteria. Compared with parenteral administration, oral antibiotics generally reach their maximum concentration later and have a lower bioavailability, but in the majority of cases adequate serum levels for bacterial killing are reached. Furthermore, studies on efficacy of oral antibiotics showed equal relapse rates (OR 0.95; 95% CI 0.79–1.16; I2 0%) or mortality (OR 1.11; 95% CI 0.72–1.72; I2 0%). Moreover, a reduction in hospital stay was observed.ConclusionsOral antibiotics administered to neonates are absorbed and result in adequate serum levels, judged by MICs of relevant pathogens, over time. Efficacy studies are promising but robust evidence is lacking, most importantly because in many cases clinical efficacy and safety are not properly addressed. Early oral antibiotic switch therapy in neonates could be beneficial for both families and healthcare systems. There is a need for additional well-designed trials in different settings.
Highlights
Infections remain a main cause of morbidity and mortality among newborns.[1]
Oral antibiotics administered to neonates are absorbed and result in adequate serum levels, judged by MICs of relevant pathogens, over time
Oral antibiotic switch therapy in neonates could be beneficial for both families and healthcare systems
Summary
Infections remain a main cause of morbidity and mortality among newborns.[1] Early-onset sepsis, defined as a proven bacterial infection in the first 72 h of life, has an overall incidence of $1/1000 live births, with a higher incidence in premature and/or very-low-birthweight infants.[2] Forty-five percent of all childhood mortality under 5 years occurs in the neonatal period, of which 22% is due to neonatal infections, including pneumonia.[3]. Diagnosis remains challenging due to non-specificity of both clinical symptoms and laboratory findings.[4] When bacterial infection is probable or proven, parenteral antibiotics are usually prescribed for at least 7 days.[5] Occasionally, when intravenous (iv) access problems occur, or when hospital referral is not possible, as in low-and-middle-income countries (LMICs), newborns are treated with oral antibiotics. Oral switch therapy has been proven effective and safe for several indications and is standard care
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