Ten Days vs. 14 days Antibiotic Therapy in Culture-Proven Neonatal Sepsis

Background: There are no evidence-based guidelines for the treatment of neonatal sepsis although standard text books recommend 14 days of antibiotics for blood culture-proven neonatal sepsis. Objective: The present study compared the effectiveness of a 10-day course of antibiotic therapy with the conventional 14-day course in blood culture-proven neonatal sepsis. Methods: Infants >= 32 weeks and >= 1.5 kg weight with blood culture-proven sepsis were randomized to either 10-day (study group) or 14-day (control group) therapy on Day 7 of appropriate antibiotic therapy, if they were in clinical remission and were C-Reactive Protein (CRP) negative. The primary outcome was treatment failure within 28 days defined by either positive CRP or positive blood culture or clinical relapse. Results: The baseline characteristics were comparable between the two groups. There was one treatment failure in each group. The duration of hospital stay was significantly shorter in the 10-day treatment group. Conclusion: Ten-day antibiotic therapy is as effective as 14-day therapy in blood culture-proven neonatal sepsis, if the infant has achieved clinical remission by Day 7 of therapy.