At a glance
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Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
In Brief
A Phase 3 clinical trial evaluating Trimethoprim-Sulfamethoxazole and Placebo for Vesicoureteral Reflux and Urinary Tract Infections. Completed, enrolled 607 participants across 19 sites.
Detailed 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.
Study Details
Timeline
Interventions
Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Cherry flavored liquid suspension matched to active comparator.