CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 607 enrolled
Drug / intervention
Trimethoprim-Sulfamethoxazole +1 moredrug
Likely dose
Trimethoprim-Sulfamethoxazole 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00405704
NCT00405704Phase 3Completed

Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Nov 30, 2006·Updated Apr 21, 2020

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 30, 2006
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 19.6 years ago

Interventions

Trimethoprim-Sulfamethoxazoledrug

Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.

Placebodrug

Cherry flavored liquid suspension matched to active comparator.