A five-day (short duration of therapy) oral Amox-clav regimen may be effective for pediatric febrile urinary tract infections, with fewer relapses within 30 days of discontinuing the therapy.

To ascertain the non-inferiority (5% threshold) of the 5-day Amoxicillin-Clavulanate (Amox-clav) course compared with the 10-day course for pediatric febrile urinary tract infection (UTI).

This randomized, controlled study randomly assigned children with non-complicated febrile UTI (aged 3 months to 5 years). They were given oral doses of Amox-clav 50+7.12 mg/kg per day in 3 split doses for 5 (short treatment group) or 10 days (standard treatment group).

The relapse of UTI within 30 days after ending the therapy was regarded as the primary endpoint. The alteration in the prevalence of clinical recovery, adverse events related to the therapy, and resistance to Amox-clav and/or to other antibiotics in case of recurrent infection were the secondary endpoints.

A total of 175 children were assessed for eligibility, of which 142 were randomly assigned from May, 2020-Sep, 2022. The recurrence rate within 30 days of therapy cessation was 2.8% (2 out of 72 children) and 14.3% (10 out of 70 children) in the short group and standard group, respectively.

The variance between the two groups was -11.51% (with a 95% confidence interval [CI] of -20.54 to -2.47). Within 30 days of antibiotic use, the recurrence rate of febrile UTIs was 1.4% (1 out of 72 children) in the 5-day treatment group and 5.7% (4 out of 70 children) in the standard group (with a 95% CI of -10.4 to 1.75).

The five-day course is non-inferior to a 10-day course of Amox-clav when administered orally.