Efficacy and safety of 5-day versus 7-day antibiotic therapy for spontaneous bacterial peritonitis in children with idiopathic nephrotic syndrome: an open-label randomized controlled trial
In brief
Five-day ceftriaxone achieves 100% clinical response versus 88% with seven days
In a randomized trial of 50 children with idiopathic nephrotic syndrome and spontaneous bacterial peritonitis, a 5-day course of intravenous ceftriaxone was non-inferior to the standard 7-day regimen, achieving full symptom resolution in all patients compared with 88% in the longer group. Bacterial cure rates and safety were similar, though fluid analysis response remained unclear.
- Journal
- Journal of tropical pediatrics (Q2)
- Published
- 20 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Hijam Kherojit, Lesa Dawman, Pujitha Vallabhaneni, Aarchie Gupta, Pallab Ray, Muralidharan Jayashree, et al.
- PMID
- 42691062
- DOI
- 10.1093/tropej/fmag060
Why clinicians should know about it
- Picked for Microbiology (medical) (top studies of the week, 6 September 2026): Antibiotic duration trial for SBP in children
Abstract
Spontaneous bacterial peritonitis (SBP) is a life-threatening complication of idiopathic nephrotic syndrome (INS) in children. Evidence on the optimal duration of antibiotics in this population is limited. We investigated whether 5-day antibiotic therapy is non-inferior to 7-day therapy for SBP in children with INS. In this single-center, open-label, randomized controlled non-inferiority trial, 50 children aged 1-14 years with INS and SBP were allocated 1:1 to intravenous ceftriaxone for 5 days (Group A, n = 25) or 7 days (Group B, n = 25). The primary outcome was composite clinical response (resolution of fever, abdominal pain, and tenderness) at the end of treatment, analyzed by intention-to-treat. The pre-specified non-inferiority margin was -15%. Secondary outcomes included bacteriological cure, cytological response, and the need for additional antibiotics. Fifty children [median age 50 (30.8-92) months] were randomized. Composite clinical response was achieved in 25/25 (100%) in Group A versus 22/25 (88%) in Group B (risk difference 12%, 95% CI -3.5% to 30.0%; P = 0.23); the lower CI bound exceeded the -15% non-inferiority margin, establishing non-inferiority. Bacteriological cure was achieved in 96% of both groups. Cytological response (64% vs 72%; P = 0.54) was inconclusive for non-inferiority. Additional or modified antibiotic therapy was required in 16% versus 20% (P = 1.00). Median hospitalization was comparable (10 vs 11 days; P > 0.05). No ceftriaxone-related adverse events were recorded. Five-day intravenous ceftriaxone is non-inferior to 7-day therapy for SBP in children with INS, with respect to composite clinical response; the secondary outcome of cytological response was inconclusive for non-inferiority.
Abstract as published, via PubMed.
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