Vesicoureteral Reflux (VUR) NIH Clinical Study

Protocol Description

The purpose of this study is to learn whether all children with vesicoureteral reflux (VUR) should be treated with antibiotics. The study will tell us if prophylactic antibiotic treatment prevents urinary tract infections (UTIs) and renal scarring in children with VUR.

VUR is a condition in which urine goes up from the bladder into the ureters during urination. VUR is found in 30 — 40 percent of children who had a UTI, and is thought to increase the risk of kidney damage when children have recurrent UTIs. Currently, children are treated with a small daily dose of antibiotics (often for several years) in hope of preventing recurrent UTIs and kidney damage. This practice has been based on information provided by a study during the 1980s in children with severe VUR who received prophylactic antibiotics or surgery; an observation group was not included in that study. There have been no well-designed research studies to show that this practice is necessary in all children with VUR.

The RIVUR Study (Randomized Intervention for Children with Vesicoureteral Reflux) is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. It will be conducted in 19 specialty clinics across the United States.

Children participating in the RIVUR Study will be randomly assigned to one of two treatment groups. One group will receive the antibiotics. The other group will receive a placebo, a liquid that looks and tastes exactly like the active medication, but contains no medicine. All children in the RIVUR study will continue in the study for 2 years, and be closely monitored for UTIs and kidney health. The study team will provide participant families with educational materials, and will stay in close contact through phone calls and study visits.

The RIVUR Study has the potential to help us understand how to provide the best care for the tens of thousands of children who are diagnosed each year with VUR and UTI.

Eligibility Criteria

• At least 2 months of age, but less than 6 years old
• First or second UTI with fever or symptoms within 16 weeks
• Effective treatment for the first UTI for at least 7 days
• VUR grade I-IV
• No history of other renal injury or serious disease
• No allergies to sulfa medications
• Meet a few additional eligibility requirements

Status: Closed to Enrollment

Additional Information

• VUR Additional Resources
• Study Personnel Directory (PDF)
• RIVUR National Website
• RIVUR study on ClinicalTrials.gov

Contact Information

For more information, contact Alejandro Hoberman, MD, Chief, Division of General Academic Pediatrics, at 412-999-3277.