Status:
COMPLETED
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Vesicoureteral Reflux
Urinary Tract Infections
Eligibility:
All Genders
2-71 years
Phase:
PHASE3
Brief 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 infect...
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled trial was designed to determine whether daily antimicrobial prophylaxis is superior to placebo in preventing recurrence of urinary tract ...
Eligibility Criteria
Inclusion
- Age at randomization: at least 2 months, but less than 6 years of age. Note that children as young as 1 month were screened for the study.
- Diagnosed first or second febrile or symptomatic UTI within 112 days prior to randomization
- Presence of Grade I- IV VUR based on radiographic voiding cystourethrogram (VCUG) performed within 112 days of diagnosis of index UTI.
- Appropriately treated index febrile or symptomatic UTI
Exclusion
- Index UTI diagnosis more than 112 days prior to randomization
- History of more than two UTIs prior to randomization
- For patients less than 6 months of age at randomization, gestational age less than 34 weeks
- Co-morbid urologic anomalies
- Hydronephrosis, SFU Grade 4
- Ureterocele
- Urethral valve
- Solitary kidney
- Profoundly decreased renal size unilaterally on ultrasound (based on 2 standard deviations below the mean for age and length) performed within 112 days after diagnosis of index UTI
- Multicystic dysplastic kidney
- Neurogenic bladder
- Pelvic kidney or fused kidney
- Known sulfa allergy, inadequate renal or hepatic function, Glucose-6-phosphate dehydrogenase deficiency or other conditions that are contraindications for use of TMP-SMZ
- History of other renal injury/disease
- Unable to complete the study protocol
- Congenital or acquired immunodeficiency
- Underlying anomalies or chronic diseases that could potentially interfere with response to therapy such as chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), liver or kidney failure, or malignancy.
- Complex cardiac disease as defined in the Manual of Procedures.
- Any known syndromes associated with VUR or bladder dysfunction
- Index UTI not successfully treated
- Unlikely to complete follow-up
- Family history of anaphylactic reaction to sulfa medications
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT00405704
Start Date
May 1 2007
End Date
May 1 2014
Last Update
April 21 2020
Active Locations (19)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614