In children with vesicoureteral reflux and at least one febrile urinary tract infection, do prophylactic antibiotics prevent recurrences or other adverse events?

Prophylactic antibiotics reduce recurrent UTI in kids with VUR (RIVUR)

Bottom Line

Antibiotic prophylaxis reduces the likelihood of recurrent urinary tract infections (UTIs) over a 2-year period (number needed to treat [NNT] = 8), but does not change the likelihood of renal scarring, at least over the medium term. This findings may lead to greater use of imaging to detect vesicoureteral reflux (VUR) in children, something that should be considered with care given the associated radiation exposure and modest benefits of prophylaxis. (LOE = 1b)Bottom Line


The RIVUR Trial Investigators, Hoberman A, Greenfield SP, et al. Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med 2014;370(25):2367-2376.

Study Design Randomized controlled trial (double-blinded) Funding Government
Setting Outpatient (specialty) Allocation Concealed


Approximately one third of children with febrile UTI have VUR, and antibiotic prophylaxis is commonly recommended to prevent recurrent infections and renal scarring and dysfunction. These investigators enrolled 607 children between the ages of 2 months and 71 months from 19 US sites. All the children had confirmed VUR (grade I to IV) and a febrile UTI within 112 days of randomization. Groups were balanced at the start of the study and the analysis was by intention to treat. The children’s median age was 12 months, with an interquartile range of 6 to 31 months; 92% of participants were female and 81% were white. The severity of VUR was grade II or III for 80% of participants. Children were randomized to receive prophylaxis with trimethoprim-sulfamethoxazole (3 mg/15 mg per kg) or matching placebo, and were followed up for 2 years. Adherence to the study medication was similar between groups. The likelihood of recurrent febrile or symptomatic UTI was significantly lower in the active treatment group (absolute risk reduction = 12%; NNT = 8). The authors calculated the results first by assuming that kids with missing data had a UTI, then by assuming that they did not, and a third time just omitting the missing data; the results were the same. There was no difference in the likelihood of renal scarring (11.9% for prophylaxis and 10.2% for placebo) or renal cortical defects. Children with grade III or IV reflux at baseline were more likely to have febrile or symptomatic recurrences than children with grade I or II reflux (22.9% vs 14.3%; P = .003). Adverse events were similar between groups.

Mark H. Ebell, MD, MS
Associate Professor
University of Georgia
Athens, GA


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