The Randomized Intervention for children with Vesicoureteral Reflux (RIVUR) Study was initiated in 2005 to assess the efficacy of antimicrobial prophylaxis in children between birth and 6 years of age diagnosed with vesicoureteral reflux (VUR) following a febrile urinary tract infection (UTI). Six hundred children identified following one or two febrile or symptomatic UTIs, who are identified as having VUR using voiding cystourethrography (VCU), are randomized to antimicrobial prophylaxis with trimethoprim/sulfamethoxazole (TMP/SMZ) or placebo. Children that are entered into the study are evaluated with initial dimercaptosuccinate (DMSA) renal scan to determine for the presence of renal scarring. Follow-up evaluation is performed with telephone contacts every 2 months and clinic visits every 6 months. VCU is performed at study end to determine persistence/resolution of VUR. DMSA renal scan is performed at 12 months and at study end at 24 months to determine new onset of renal scarring. Additionally, development of antibiotic resistance is assessed with the use of fecal cultures obtained at follow-up visits. Primary study aims are to determine if the use of antibiotic prophylaxis (i) reduces the incidence of UTI or delays the time to recurrent UTIs in children with VUR, (ii) increases the development of resistant E. coli or increases the incidence of UTIs caused by E. coli and (iii) leads to reduction in the development of renal scarring. The protocol of the RIVUR study was developed as a consensus between the investigators from five core clinical centers and the data coordinating center along with input from the NIH/NIDDK. As of October 2009, 370 children have been recruited into the study and are being followed for 2 years. The primary aim of the extension is to complete recruitment and follow-up of the study cohort.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK074082-08
Application #
8323112
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
$186,841
Indirect Cost
$55,296
Name
Johns Hopkins University
Department
Urology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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
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
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
Smith, Lorie B; Fadrowski, Jeffrey J; Howe, Chanelle J et al. (2010) Secondary hyperparathyroidism and anemia in children treated by hemodialysis. Am J Kidney Dis 55:326-34