• Ron Keren, Myra A Carpenter, Alejandro Hoberman, Nader Shaikh, Tej K Matoo, Russell W Chesney, Ranjiv Matthews, Arlene C Gerson, Saul P Greenfield, Barbara Fivush, Gordon A McLurie, H Gil Rushton, Douglas Canning, Caleb P Nelson, Lawrence Greenbaum, Timothy Bukowski, William Primack, Richard Sutherland, James Hosking, Dawn Stewart, Jack Elder, Marva Moxey-Mims, and Leroy Nyberg.
• Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA. keren@email.chop.edu
• Pediatrics. 2008 Dec 1;122 Suppl 5:S240-50.

ObjectiveOur goal is to determine if antimicrobial prophylaxis with trimethoprim/sulfamethoxazole prevents recurrent urinary tract infections and renal scarring in children who are found to have vesicoureteral reflux after a first or second urinary tract infection.Design, Participants, And MethodsThe Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is a double-blind, randomized, placebo-controlled trial. Six hundred children aged 2 to 72 months will be recruited from both primary and subspecialty care settings at clinical trial centers throughout North America. Children who are found to have grades I to IV vesicoureteral reflux after the index febrile or symptomatic urinary tract infection will be randomly assigned to receive daily doses of either trimethoprim/sulfamethoxazole or placebo for 2 years. Scheduled follow-up contacts include in-person study visits every 6 months and telephone interviews every 2 months. Biospecimens (urine and blood) and genetic specimens (blood) will be collected for future studies of the genetic and biochemical determinants of vesicoureteral reflux, recurrent urinary tract infection, renal insufficiency, and renal scarring.ResultsThe primary outcome is recurrence of urinary tract infection. Secondary outcomes include time to recurrent urinary tract infection, renal scarring (assessed by dimercaptosuccinic acid scan), treatment failure, renal function, resource utilization, and development of antimicrobial resistance in stool flora.ConclusionsThe RIVUR study will provide useful information to clinicians about the risks and benefits of prophylactic antibiotics for children who are diagnosed with vesicoureteral reflux after a first or second urinary tract infection. The data and specimens collected over the course of the study will allow researchers to better understand the pathophysiology of recurrent urinary tract infection and its sequelae.

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