STOP
Trial question
Is 5-day antibiotic therapy noninferior to 10-day antibiotic therapy in pediatric febrile UTI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
66.0% female
34.0% male
N = 142
142 patients (94 female, 48 male).
Inclusion criteria: children, aged 3 months to 5 years, with a noncomplicated febrile UTI.
Key exclusion criteria: age < 3 months or > 5 years; complicated UTI.
Interventions
N=72 short-course antibiotics (a 5-day regimen of amoxicillin/clavulanate PO 50/7.12 mg/kg/day in 3 divided doses).
N=70 long-course antibiotics (a 10-day regimen of amoxicillin/clavulanate PO 50/7.12 mg/kg/day PO in 3 divided doses).
Primary outcome
Rate of recurrence of urinary tract infections within 30 days of end of therapy
2.8%
14.3%
14.3 %
10.7 %
7.2 %
3.6 %
0.0 %
Short-course
antibiotics
Long-course
antibiotics
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of recurrence of UTIs within 30 days of end of therapy (2.8% vs. 14.3%; ARD -11.51, 95% CI -20.54 to -2.47).
Secondary outcomes
Borderline significant decrease in the rate of recurrence of febrile UTIs within 30 days of end of therapy (1.4% vs. 5.7%; ARD -4.33, 95% CI -10.4 to 1.75).
Conclusion
In children, aged 3 months to 5 years, with a noncomplicated febrile UTI, short-course antibiotics were noninferior to long-course antibiotics with respect to the rate of recurrence of UTIs within 30 days of end of therapy.
Reference
Giovanni Montini, Antimo Tessitore, Karen Console et al. Short Oral Antibiotic Therapy for Pediatric Febrile Urinary Tract Infections: A Randomized Trial. Pediatrics. 2024 Jan 1;153(1):e2023062598.
Open reference URL