Urinary antibiotic prophylaxis may not be required in children with mild or moderate vesicoureteral reflux following acute pyelonephritis

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Garin EH, Olavarria F, Garcia Nieto V, Valenciano B, Campos A, Young L. Clinical significance of primary vesicoureteral reflux and urinary antibiotic prophylaxis after acute pyelonephritis: A multicenter, randomized, controlled study. Pediatrics 2006;117:626-32.

Question Among children with mild/moderate vesicoureteral reflux (VUR), does urinary antibiotic prophylaxis reduce the frequency and/or severity of urinary tract infections (UTIs) and/or prevent renal parenchymal damage?

Design Randomized controlled trial.

Setting Four centers in Florida, Chile, and Spain.

Participants Children 3 months to 18 years of age with acute pyelonephritis, with or without VUR.

Intervention Children were assigned to receive urinary antibiotic prophylaxis (with trimethoprim/sulfamethoxazole or nitrofurantoin) or not. They were monitored every 3 months for 1 year. Dimercaptosuccinic acid renal scans were repeated at 6 months or if there was a recurrence of febrile UTI. Urinalysis and urine culture were performed at each clinic visit. Renal ultrasonography scans and voiding cystourethrograms (VCUGs) were repeated at the end of 1 year of follow-up monitoring.

Outcomes Rates and types of recurrent UTIs and development of renal scars.

Results Of the 236 patients enrolled in the study, 218 completed the 1-year follow-up monitoring. Groups were similar with respect to age, sex, and reflux grade distribution for those with VUR. No statistically significant differences were found among the groups with respect to rate of recurrent UTI, type of recurrence, rate of subsequent pyelonephritis, and development of renal parenchymal scars.

Conclusions After 1 year of follow-up monitoring, mild/moderate VUR does not increase the incidence of UTI, pyelonephritis, or renal scarring after acute pyelonephritis. Moreover, a role for urinary antibiotic prophylaxis in preventing the recurrence of infection and the development of renal scars is not supported by this study.

Comment Prophylactic antimicrobials are routinely prescribed in the management of young children with radiologic evidence of VUR following an episode of acute pyelonephritis. Prophylaxis is generally maintained until the VUR resolves spontaneously or is corrected surgically. This standard emerged based on the biologic plausibility that such a strategy would be beneficial rather than on evidence derived from systematic study. Garin et al have provided compelling data indicating that urinary tract prophylaxis with currently available agents in children with low grades of VUR (I, II, and III) does not seem to be beneficial in either preventing the recurrence of infection or in the development of renal scars. Unfortunately, antimicrobial treatment of the acute episode was not standardized, and a placebo was not administered to the control group. Neither subjects nor physicians were blinded to the treatment assignment. The microbiology of initial and breakthrough episodes of UTI was not provided. Children who experienced two episodes of pyelonephritis during the year were excluded from analysis, as were children who were not adherent to their prophylactic therapy. Most worrisome of the methodologic problems, which weakens the study, was the performance of the primary analysis only on patients who completed the 1 year follow-up; an intention-to-treat analysis was not performed. Additional studies addressing this important question are warranted. Garin et al’s conclusion that antimicrobial prophylaxis is not effective in preventing infection or scarring may not apply to children with higher degrees of reflux. Until such time that there are data to address the usefulness of prophylaxis in these latter cases, we must continue to recommend the performance of the VCUG to determine the presence of VUR and search for strategies to keep the urine free of infection in children with high degrees of reflux.