The Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial was funded September 30, 2005. The RIVUR study is a multi-center, randomized controlled trial designed to determine whether daily antimicrobial prophylaxis with TMP/SMZ is superior to placebo in preventing recurrent urinary tract infection (UTI) in children diagnosed with vesicoureteral reflux (VUR). RIVUR will also evaluate whether antimicrobial prophylaxis is superior to placebo in modifying the level of renal scarring present at the end of the study.
Other aims of the study include evaluating outcomes related to treatment failures, presence of drug resistant bacteria, health-related quality of life, resource utilization, and measures of renal function. Study investigators planned to enroll 600 children with grades l-IV VUR following first or second febrile or symptomatic UTI, but the enrollment target was not met during the original award period. To date, approximately 400 children have been enrolled across all the clinical trial sites. Recruitment projections indicate that the 3-year continuation grant would allow successful enrollment of 600 children , 2-year follow p of the last enrolled child, with time remaining to complete the data analysis and manuscript preparation.

Public Health Relevance

The current standard of care for children with VUR following treatment of UTI is antibiotic prophylaxis. However, there is little clinical trial evidence to support the efficacy of this long-term therapy in reducing recurrent UTI or preventing renal scarring. Multiple expert committees have recommended that a well-designed placebo-controlled trial be conducted to determine if antibiotic prophylaxis in children with VUR reduces the incidence of pyelonephritis and development of renal scars.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK074064-08
Application #
8323111
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (M2))
Program Officer
Moxey-Mims, Marva M
Project Start
2005-09-30
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
8
Fiscal Year
2012
Total Cost
$195,818
Indirect Cost
$104,460
Name
Children's Hospital of Philadelphia
Department
Type
DUNS #
073757627
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
RIVUR Trial Investigators; Hoberman, Alejandro; Greenfield, Saul P et al. (2014) Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med 370:2367-76
Bhatnagar, Sonika; Hoberman, Alejandro; Kearney, Diana H et al. (2014) Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial. Clin Pediatr (Phila) 53:151-7
Carpenter, Myra A; Hoberman, Alejandro; Mattoo, Tej K et al. (2013) The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux. Pediatrics 132:e34-45