309 children ages 1 to 24 months with fever ≥38.3°C, pyuria, bacteriuria, and growth of ≥50,000 colony forming units (CFU)/mL on culture from a catheterized sample. Select exclusion criteria: Gram-positive cocci in urine, alternative source of fever, underlying chronic disease, severe illness, history of UTI, or structural urinary tract abnormality.

Patients received a 14-day course of cefixime 8 mg/kg/d PO (double-strength dose on day 1) vs. cefotaxime 200 mg/kg/d IV for 3 days (or until afebrile for ≥24 hours, whichever longer), followed by cefixime PO to complete 14 days. Both groups then received prophylaxis with cefixime (4 mg/kg once daily) for 2 weeks until completion of a voiding cystourethrogram (VCUG). Children with vesicoureteral reflux (VUR) of grade 2 or higher were maintained on prophylaxis for 11 months, or until the reflux was grade 1 or resolved.