Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

Completed · Phase 3 · Has a placebo group

Conditions studied: Vesicoureteral Reflux, Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT00405704

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

607

Starts

2007-05-01

Expected to finish

2014-05-01

Last updated by the study team

2020-04-21

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Children's Hospital of Boston — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Wisconsin Children's Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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