Published online November 18, 2008
PEDIATRICS Vol. 122 Supplement December 2008, pp. S240-S250 (doi:10.1542/peds.2008-1285d)

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SUPPLEMENT ARTICLE

Rationale and Design Issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) Study

Ron Keren, MD, MPH^a, Myra A. Carpenter, PhD^b, Alejandro Hoberman, MD, MPH^c, Nader Shaikh, MD, MPH^c, Tej K. Matoo, MD^d, Russell W. Chesney, MD^e, Ranjiv Matthews, MD^f, Arlene C. Gerson, MD^g, Saul P. Greenfield, MD^h, Barbara Fivush, MD^g, Gordon A. McLurie, MD^h, H. Gil Rushton, MDⁱ, Douglas Canning, MD^j, Caleb P. Nelson, MD^k, Lawrence Greenbaum, MD, PhD^l, Timothy Bukowski, MD^m, William Primack, MDⁿ, Richard Sutherland, MD^m, James Hosking, PhD^b,, Dawn Stewart, MS^b, Jack Elder, MD^o, Marva Moxey-Mims, MD^p, Leroy Nyberg, MD^p

^a Departments of Pediatrics
^j Urology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
^b Departments of Biostatistics
^m Urology
ⁿ Pediatrics, University of North Carolina, Chapel Hill, North Carolina
^c Department of Pediatrics, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
^d Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan
^e Department of Pediatrics, Le Bonheur Children's Medical Center, Memphis, Tennessee
^f Departments of Urology
^g Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland
^h Department of Urology, Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina
ⁱ Department of Urology, Children's National Medical Center, Washington, DC
^k Department of Urology, Children's Hospital Boston, Boston, Massachusetts
^l Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia
^o Department of Urology, Rainbow Babies and Children's Hospital, Cleveland, Ohio
^p National Institute of Diabetes and Digestive Kidney Disease, National Institutes of Health, Bethesda, Maryland

OBJECTIVE. Our 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 METHODS. The 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.

RESULTS. The 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.

CONCLUSIONS. The 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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Key Words: urinary tract infection • vesicoureteral reflux • antimicrobial prophylaxis • randomized • controlled trial • renal scarring

Abbreviations: RIVUR—Randomized Intervention for Children With Vesicoureteral Reflux • VUR—vesicoureteral reflux • UTI—urinary tract infection • TMP/SMZ—trimethoprim/sulfamethoxazole • _F/SUTI—febrile or symptomatic UTI • VCUG—voiding cystourethrogram • DMSA—dimercaptosuccinic acid • G6PD—glucose-6-phosphate dehydrogenase • APN—acute pyelonephritis • DVSS—dysfunctional voiding scoring system • PACCT—Paris Consensus on Childhood Constipation Terminology • MEMS—Medication Event Monitoring System

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Accepted Jun 6, 2008.

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