7-days versus 14-days antibiotic therapy in uncomplicated culture proven neonatal sepsis: a randomized control assessor-blinded trial

Clinical Snapshot

Key Findings

• P Value: p < 0.05 for secondary outcomes (hospital stay and respiratory support)

• Effect Size: Non-inferiority demonstrated for 7-day versus 14-day therapy

• Primary Outcome: Low incidence of probable relapse in both groups with no definitive relapses recorded

• Nnt Or Sensitivity: Not calculable from available data - non-inferiority margin not specified

• Confidence Interval: Not reported in abstract

Clinical Application

Highly feasible - requires only modification of existing antibiotic protocols without additional resources Directly applicable to Australian NICUs; aligns with antimicrobial stewardship principles supported by NHMRC and TGA guidelines on judicious antibiotic use Term and near-term neonates (≥1000g) with uncomplicated culture-positive sepsis in tertiary NICUs

Abstract

UNLABELLED: The trial aimed to establish the non-inferiority of a 7-day antibiotic therapy for uncomplicated neonatal sepsis when compared to the standard 14-day therapy. This study was a parallel-group, randomized non-inferiority assessor-blinded trial conducted in a tertiary Neonatal Intensive Care Unit in Central India. Neonates weighing ≥ 1000 g with suspected sepsis were screened and those meeting criteria were enrolled. Exclusions included babies with CNS (central nervous system) infections, septic arthritis, and life-threatening congenital malformations. Participants were observed for 7 days on antibiotics and re-evaluated; those with positive blood cultures were then randomized to receive either 7 or 14 days of antibiotics. The primary outcome was the relapse of sepsis, and a sample size of 70 in each arm was calculated based on a non-inferiority margin. Follow-ups were conducted for 48 h post-antibiotic treatment and weekly for 35 days to monitor any recurrence of illness. During the study, 917 babies with suspected sepsis were admitted, of which 256 had culture-positive sepsis. After excluding those with meningitis, staphylococcus, and fungal infections, 140 babies showed improvement at day 5 and were randomized into two groups: one receiving antibiotics for 7 days and the other for 14 days, each consisting of 70 babies. Klebsiella pneumoniae was the prevalent organism. The 7-day group had a shorter hospital stay (p < 0.05) and less respiratory support (p < 0.05). Outcomes revealed a low incidence of probable relapse in both groups, with no fatalities or definitive relapses recorded. CONCLUSIONS: A 7-day antibiotic regimen for uncomplicated neonatal sepsis is not inferior to a 14-day regimen. WHAT IS KNOWN: • Unregulated use of antibiotics can lead to a myriad of problems, especially in neonates. • There is some evidence that uncomplicated neonatal sepsis can be treated with short-course antibiotics. WHAT IS NEW: • Data is lacking-especially from Central India. • This trial checks if it is possible to reduce the duration of antibiotic therapy in uncomplicated neonatal sepsis.

References

1. 1.Jain, A., Agarwal, N., Anand, R., Padhi, P., & Jindal, A. (2026). 7-days versus 14-days antibiotic therapy in uncomplicated culture proven neonatal sepsis: a randomized control assessor-blinded trial. European Journal of Pediatrics. https://doi.org/10.1007/s13312-011-0019-8