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URL: http://www.cscc.unc.edu/rivur/
Proper Citation: RiVuR (RRID:SCR_001539)
Description: Multicenter, randomized, double-blind, placebo-controlled trial is designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract infection (UTI) in children with vesicoureteral reflux (VUR). The basic eligibility criteria are: (1) age at randomization of at least 2 months, but less than 6 years, (2) a diagnosed first febrile or symptomatic UTI within 42 days prior to randomization that was appropriately treated, and (3) presence of Grade I-IV VUR based on voiding cystourethrogram (VCUG). Patients will be randomly assigned to treatment for 2 years with daily antimicrobial prophylaxis (trimethoprim-sulfamethoxazole) or placebo. The study is designed to recruit 600 children (approximately 300 in each treatment group) over an 18-24 month period. The primary endpoint is recurrence of UTI. In addition, patients will be evaluated for secondary endpoints related to renal scarring and antimicrobial resistance. Scarring will be determined based on renal scintigraphy by 99mTc dimercaptosuccinic (DMSA) scan. Quality of life, compliance, safety parameters, utilization of health resources, and change in VUR will be assessed periodically throughout the study.
Abbreviations: RIVUR
Synonyms: Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR), Randomized Intervention for Children with Vesicoureteral Reflux, Randomized Intervention for Vesicoureteral Reflux
Resource Type: resource, clinical trial
Defining Citation: PMID:19570724, PMID:19018048, PMID:18076937, PMID:19018047, PMID:19086141
Keywords: child, antimicrobial prophylaxis, placebo, antibiotic, renal scarring, pediatric, trimethoprim-sulfamethoxazole, intervention, kidney, antibiotic resistance, young human, infant, bibliography, clinical, trimethoprim, sulfamethoxazole
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University of North Carolina at Chapel Hill; North Carolina; USA |
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