Seven-day versus 14-day antibiotic course for culture-proven neonatal sepsis: a multicentre randomised non-inferiority trial in a low and middle-income country.
Summary
In a multicentre non-inferiority RCT, a 7-day antibiotic regimen was non-inferior to 14 days for uncomplicated culture-proven neonatal sepsis. Relapse within 21 days post-therapy was similar or lower with 7 days, and hospital stay was shorter by a median of 4 days.
Key Findings
- Seven-day antibiotics were non-inferior to 14-day therapy for uncomplicated neonatal sepsis.
- Primary outcome (relapse within 21 days post-completion): 2/125 vs 6/130 (risk difference −3.0%, 99.5% CI −9.2% to +3.1%).
- Composite secondary outcome favored 7 days, and median hospital stay was 4 days shorter.
Clinical Implications
For clinically improving neonates with culture-proven sepsis, a 7-day course may be adequate, reducing hospital days and antibiotic exposure. Implementation should consider inclusion criteria (BW ≥1000 g, remission by day 7) and local pathogens.
Why It Matters
Provides high-quality evidence to safely shorten antibiotic duration in neonatal sepsis, with implications for antimicrobial stewardship, costs, and resistance.
Limitations
- Early trial termination after interim per-protocol analysis
- Generalizability limited to neonates ≥1000 g with clinical remission by day 7; clinician blinding not described
Future Directions
Confirmatory pragmatic RCTs across diverse settings and weight strata, evaluation of pathogen-specific risks, and stewardship implementation studies.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Multicentre randomized controlled trial with masked outcome assessment
- Study Design
- OTHER