Use of procalcitonin in neonatal late-onset sepsis may reduce the duration of antibiotic therapy without increase in mortality

1. Incorporating procalcitonin-guided decision making in the management of neonatal late-onset sepsis significantly reduced the duration of antibiotic treatment without increasing mortality.

Evidence Rating Level: 1 (Excellent)

Late-onset neonatal sepsis, defined as sepsis occurring after 72 hours of life, is a common neonatal disease. However, the optimal duration of antimicrobial therapy is not well established, and there is a growing body of literature on the risks of prolonged antibiotic exposure in newborns. Procalcitonin has been incorporated into clinical algorithms to reduce antibiotic duration without increasing mortality in critically ill patients. It is unclear if procalcitonin levels can be used to guide antibiotic use in late-onset neonatal sepsis. This prospective, multicentre, randomised, open-label intervention trial included newborns in neonatal intensive care units of postconceptional age 24-45 weeks and after 4 days of life, with suspected or proven late-onset sepsis (defined as onset three days after birth,17 and for whom the treating physician had planned to continue antibiotic treatment beyond 48 hours’ duration). 513 patients were randomized to procalcitonin-guided treatment (n = 248; median (IQR) gestational age at inclusion, 31.0 (28.9-34.0) weeks; median (IQR) number of days of life at inclusion, 14.0 (10.0-24.0) days; 47.2% female) or usual care (n = 256; median (IQR) gestational age at inclusion, 31.3 (29.1-33.6) weeks; median (IQR) number of days of life at inclusion, 13.0 (9.0-23.0) days; 45.3% female). In the procalcitonin group, patients had procalcitonin concentration measured at randomisation and then every two days. If the concentration was 0.5 µg/L or lower, physicians were encouraged to discontinue antibiotics. The median duration of antibiotic treatment was significantly shorter in the procalcitonin-guided group versus the usual care group (median (IQR) 8 (5.0-12.0) days vs. 10 (8.0-13.0) days; absolute difference −2.0 (IQR −3.8 to −1.0), P<0.001). There were six (2.4%) deaths in the procalcitonin-guided group and ten (3.9%) in the usual care group (absolute difference −1.5% (95% CI −5.0% to 1.8%), below the prescribed non-inferiority margin of 3%. Overall, the use of procalcitonin significantly reduced the duration of antibiotic treatment in neonatal late-onset sepsis without increasing mortality or serious adverse events.

Click here to read this study in BMJ Medicine

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