A randomized trial conducted in Italy showed that a 5-day course of antibiotics in children with febrile urinary tract infection (fUTI) was noninferior to 10 days, researchers reported this week in Pediatrics.
In the multicenter trial, a team led by investigators from the University of Trieste randomly assigned children aged 3 months to 5 years with noncomplicated fUTI to receive oral amoxicillin-clavulanate in three divided doses for 5 days or the standard 10 days. The primary endpoint was the recurrence of a UTI within 30 days after treatment. Secondary endpoints included clinical recovery at end of treatment, adverse drug-related events, and resistance to amoxicillin-clavulanate or other antibiotics when a recurrent UTI occurred. The noninferiority threshold was 5 percentage points.
Lower UTI recurrence in the 5-day group
Of the 175 children assessed for eligibility, 142 underwent randomization, with 72 assigned to the 5-day arm and 70 to the 10-day arm. The recurrence rate of all UTIs (febrile and non-febrile) within 30 days from the end of therapy was 2.8% in the short group and 14.3% in the standard group, for a between-group difference of –11.51 percentage points (95% confidence interval [CI], –20.52 to –2.47). The recurrence rate of fUTI within 30 days from the end of therapy was 1.4% in the short group and 5.7% in the standard group (difference, –4.33 percentage points; 95% CI, –10.40 to 1.75).
Resolution of signs and symptoms occurred in 97.2% of cases in the short group, and 92.9% in the standard group. The frequency of adverse events was 1.4% in the short group, with none reported in the standard group. The emergence of antibiotic resistance to amoxicillin-clavulanate or other antibiotics did not differ between the two treatment groups.
"To our knowledge, this is the first study in the literature concerning brief therapy in UTIs," the study authors wrote. "Further trials are needed to confirm these results."