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.
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.
| Mattoo, Tej K; Skoog, Steven J; Gravens-Mueller, Lisa et al. (2017) Interobserver variability for interpretation of DMSA scans in the RIVUR trial. J Pediatr Urol 13:616.e1-616.e6 |
| Schaeffer, Anthony J; Greenfield, Saul P; Ivanova, Anastasia et al. (2017) Reliability of grading of vesicoureteral reflux and other findings on voiding cystourethrography. J Pediatr Urol 13:192-198 |
| Primack, William; Bukowski, Timothy; Sutherland, Richard et al. (2017) What Urinary Colony Count Indicates a Urinary Tract Infection in Children? J Pediatr 191:259-261.e1 |
| Nelson, Caleb P; Hoberman, Alejandro; Shaikh, Nader et al. (2016) Antimicrobial Resistance and Urinary Tract Infection Recurrence. Pediatrics 137: |
| Mattoo, Tej K; Chesney, Russell W; Greenfield, Saul P et al. (2016) Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial. Clin J Am Soc Nephrol 11:54-61 |
| Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Predictors of Antimicrobial Resistance among Pathogens Causing Urinary Tract Infection in Children. J Pediatr 171:116-21 |
| Schwaderer, Andrew L; Wang, Huanyu; Kim, SungHwan et al. (2016) Polymorphisms in ?-Defensin-Encoding DEFA1A3 Associate with Urinary Tract Infection Risk in Children with Vesicoureteral Reflux. J Am Soc Nephrol 27:3175-3186 |
| Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Recurrent Urinary Tract Infections in Children With Bladder and Bowel Dysfunction. Pediatrics 137: |
| Shaikh, Nader; Mattoo, Tej K; Keren, Ron et al. (2016) Early Antibiotic Treatment for Pediatric Febrile Urinary Tract Infection and Renal Scarring. JAMA Pediatr 170:848-54 |
| Keren, Ron; Shaikh, Nader; Pohl, Hans et al. (2015) Risk Factors for Recurrent Urinary Tract Infection and Renal Scarring. Pediatrics 136:e13-21 |
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