Ten- vs. 14-day antibiotic therapy for culture-positive neonatal sepsis

Abstract

Abstract Background Neonatal sepsis is a major determinant of neonatal mortality. There is a scarcity of evidence-based guidelines for the duration of antibiotics in culture-positive sepsis. Objectives The aim of this study was to compare the efficacy of 10- and 14-day antibiotic therapies in the management of culture-positive neonatal sepsis. Methods This randomized controlled trial was conducted in the neonatal intensive care unit of a tertiary care center among the neonates suffering from culture-positive sepsis (with signs of clinical remission on day 9 of antibiotic) between January 2023 and May 2023. Newborns with major congenital anomaly, deep-seated infections, multi-organ dysfunction, associated fungal infections/infection by multiple organisms and severe birth asphyxia were excluded. Two hundred and thirty-four newborns were randomized into two groups—study (received 10 days of antibiotics) and control (received 14 days of antibiotics). Treatment failure, hospital stay and adverse effects were compared between the two groups. p < 0.05 was taken as the limit of statistical significance. Results Median [interquartile range (IQR)] birth weight and gestational age of the study population (53.8% boys) were 2.424 kg (IQR: 2.183–2.695) and 37.3 weeks (IQR: 35.5–38.1), respectively. Acinetobacter was the most commonly isolated species (56, 23.9%). The baseline characteristics of both groups were almost similar. Treatment failure was similar in the study and control groups (3.8% vs. 1.7%, p = 0.40), with a shorter hospital stay [median (IQR): 14 (13–16) vs. 18 (17–19) days, p < 0.001]. Conclusion Ten-day antibiotic therapy was comparable with 14-day antibiotic therapy in efficacy, with a shorter duration of hospital stay and without any significant increase in adverse effects.