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Oral antibiotics for neonatal infections: a systematic review and meta-analysis
Fleur M Keij1,2, René F Kornelisse1, Nico G Hartwig2
1Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Insights
Oral antibiotics are absorbed in neonates, reaching adequate levels for bacterial killing. While efficacy studies are promising, more research is needed to confirm safety and effectiveness of oral switch therapy in newborns.
Area of Science:
- Neonatal pharmacology
- Pediatric infectious diseases
- Antibiotic stewardship
Background:
- Neonatal bacterial infections necessitate treatment, often involving prolonged intravenous antibiotic therapy.
- Oral switch therapy is established in older children but understudied in neonates.
- Intravenous administration leads to extended hospital stays for neonates.
Purpose of the Study:
- To systematically review evidence on oral antibiotics and switch therapy in neonates (0-28 days old).
- To evaluate pharmacokinetics, safety, and efficacy of oral antibiotic use in this population.
- To assess the potential for reducing hospitalization duration.
Main Methods:
- Conducted systematic searches across major scientific databases (Medline, Embase, Cochrane, Google Scholar, Web of Science).
- Included studies detailing oral antibiotic use or switch therapy in neonates (0-28 days old).
- Focused on pharmacokinetic, safety, and efficacy data.
Main Results:
- Thirty-one studies met inclusion criteria.
- Oral antibiotics showed delayed peak concentrations and lower bioavailability but achieved adequate serum levels for bacterial killing in most cases.
- Efficacy studies indicated comparable relapse rates and mortality to parenteral routes, with observed reductions in hospital stay.
Conclusions:
- Oral antibiotics are absorbed in neonates, achieving therapeutic serum concentrations.
- Efficacy and safety data are promising but require more robust evidence from well-designed trials.
- Early oral switch therapy in neonates offers potential benefits for families and healthcare systems.
Background:
Worldwide 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.
Objectives:
To evaluate the currently available evidence on pharmacokinetics, safety and efficacy of oral antibiotics and oral switch therapy in neonates (0-28 days old).
Methods:
We 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.
Results:
Thirty-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.
Conclusions:
Oral 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.
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