Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

Summary

In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.

Conditions

• Vesicoureteral Reflux
• Urinary Tract Infections

Interventions

DRUG

Trimethoprim-Sulfamethoxazole

Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.

DRUG

Placebo

Cherry flavored liquid suspension matched to active comparator.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Sahar Fathallah, MD · University of Alabama, Birmingham, AL

• Myra A Carpenter, PhD · University of NC at Chapel Hill, Chapel Hill, NC

• Caleb P. Nelson, MD, MPH · Children's Hospital of Boston, Boston, MA

• Eileen Brewer, MD · Texas Children's Hospital, Houston, TX

• Saul P Greenfield, MD · Women and Children's Hospital of Buffalo, Buffalo, NY

• Alejandro Hoberman, MD · Children's Hospital of Pittsburgh, Pittsburgh, PA

• Ron Keren, MD, MPH · Children's Hospital of Philadelphia, Philadelphia, PA

• Bradley P Kropp, MD · University of Oklahoma, Oklahoma City, OK

• Ranjiv Mathews, MD · Johns Hopkins University

• Tej K Mattoo, MD,DCH, FRCP · Wayne State University School of Medicine, Detroit, MI

• H. Gil Rushton, MD, FAAP · Children's National Research Institute

• Mary Ann Queen, MD · Children's Mercy Hospital Kansas City

• Russell W Chesney, MD · Le Bonheur Children's Medical Center, Memphis, TN

• Steven J Skoog, MD FACS,FAAP · Oregon Health & Science University, Portland, OR

• Amy Renwick, MD · Alfred I. duPont Hospital for Children, Wilmington, DE

• Earl Y. Cheng, MD · Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL

• Milan Nadkarni, MD · Wake Forest University Baptist Medical Center, Winston-Salem, NC

• Caleb P Nelson, MD, MPH · Children's Hospital of Boston, Boston, MA

• William R DeFoor, Jr, MD, MPH · Cincinnati Children's Hospital, Cincinnati, OH

• Dan McMahon, MD · Akron Children's Hospital, Akron, OH

• Ross Decter, MD · Penn State Hershey Medical Center, Hershey, PA

• Sharon M Bartosh, MD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

71 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2013-06-30

Completion

2014-05-31

FDA Drug

Yes

Countries

• United States

Study Locations