Abstract
Objective
On 2/2019, the Neonatal Antimicrobial Stewardship Program at Nationwide Children’s Hospital recommended reducing empirical antibiotic therapy for early-onset sepsis (EOS) from 48 to 24 hours with a TIME-OUT. We describe our experience with this guideline and assess its safety.
Methods
Retrospective review of newborns evaluated for possible EOS at 6 NICUs from 12/2018-7/2019. Safety endpoints were re-initiation of antibiotics within 7 days after discontinuation of the initial course, positive bacterial blood or cerebrospinal fluid culture in the 7 days after antibiotic discontinuation, and overall and sepsis-related mortality.
Result
Among 414 newborns evaluated for EOS, 196 (47%) received a 24 hour rule-out sepsis antibiotic course while 218 (53%) were managed with a 48 hour course. The 24-hour rule-out group were less likely to have antibiotics re-initiated and did not differ in the other predefined safety endpoints.
Conclusion
Antibiotic therapy for suspected EOS may be discontinued safely within 24 hours.
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Data availability
The de-identified dataset generated from the study is available from the corresponding author on reasonable request and following approval by the Institutional Review Board of Nationwide Children’s Hospital.
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Acknowledgements
The authors wish to thank Alexandra K. Medoro, MD, Joshua R. Watson, MD, Gregory Ryshen, BS, MS, MBA, Melinda Albertson, NNP, Caitlyn Schwirian, PharmD, Wai-Yin Mandy Tam, PharmD, Tommy Nathaniel Johnson-Roddenberry, DNP, NNP-BC, and Maria Jebbia, MD at Nationwide Children’s Hospital for their support of the short course empirical antibiotic therapy for early-onset sepsis guidance. The study was presented virtually and in part at the Pediatric Academic Societies Meeting on 8/4/2020.
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PJS conceptualized and designed the study, coordinated and supervised data collection, and drafted and revised the manuscript. PP conceptualized and designed the study, designed the data collection instruments, collected data, carried out the initial analyses, and reviewed and revised the manuscript. CdeAR collected and helped to analyze the data, reviewed and revised the manuscript, and approved the final manuscript as submitted. EZ-F collected and helped to analyze the data, reviewed and revised the manuscript, and approved the final manuscript as submitted. MCRE collected and helped to analyze the data, reviewed and revised the manuscript, and approved the final manuscript as submitted. NOW conceptualized and designed the study, reviewed and revised the manuscript. RRM conceptualized and designed the study, reviewed and revised the manuscript. RM conceptualized and designed the study, reviewed and revised the manuscript. ART conceptualized and designed the study, reviewed, and revised the manuscript. JKM conceptualized and designed the study, collected data, reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
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PP received grant funding from Merck & Co. unrelated to this study. Other authors have no conflicts of interest relevant to this article to disclose.
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Sánchez, P.J., Prusakov, P., de Alba Romero, C. et al. Short-course empiric antibiotic therapy for possible early-onset sepsis in the NICU. J Perinatol 43, 741–745 (2023). https://doi.org/10.1038/s41372-023-01634-3
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DOI: https://doi.org/10.1038/s41372-023-01634-3
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