Welcome to the RIVUR Study
Research Goal
The goal of this study is to learn whether daily doses of antibiotics prevent urinary tract infections (UTIs) and kidney damage in children with vesicoureteral reflux (VUR). This study has the potential to help us understand how to provide the best care for tens of thousands of children who are diagnosed with VUR each year.
Research Summary
VUR is a condition in which urine travels from the bladder into the ureters during urination. It happens in 30 to 40 percent of children who have had a urinary tract infection (UTI). VUR is thought to increase the risk of kidney damage when children have recurrent UTIs.
Children who have VUR are treated with a small daily dose of antibiotics in an effort to prevent recurrent UTIs and kidney damage.
The Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study is designed to determine whether daily doses of antibiotics prevent UTIs and kidney damage in children between the ages of 2 months to 6 years old who have VUR. The study is sponsored by the National Institutes of Health (NIH) and is being conducted in more than 15 children's hospitals across the United States and Canada.
Children participating in the RIVUR study will be randomly assigned to one of two treatment groups. One group will receive an active antibiotic medication. The other group will receive a placebo — a liquid that looks and tastes exactly like the active medication but contains no medicine.
If your child takes part in the study, you will be asked to give your child the study medication once a day every day and to come to study visits every six months (a total of five visits over two years). The first and last study visits will take place at The Children's Hospital of Philadelphia or the Children's Hospital Specialty Care Center in King of Prussia. All other study visits can take place at either of these locations or at any Children's Hospital Specialty Care Center near you.
Children in the RIVUR study will be closely monitored for UTIs and kidney health for two years. The study team will provide participants' families with educational materials about VUR and UTIs and will stay in close contact with families through phone calls and study visits.
At all RIVUR study visits we will:
- Conduct a basic physical exam
- Review your child's medical records
- Check for side effects from the study medication
- Ask you to complete a short questionnaire about how UTIs and VUR affect your child's quality of life
- Compensate you for your travel expenses and time away from work
At some RIVUR study visits we will:
- Take pictures of your child's kidneys (using a special test called a renal scan) to look for the development of kidney damage
- Obtain blood and urine to monitor your child's kidney function and response to the study medication
- Obtain a small stool sample to check for the development of resistant bacteria
- Conduct a test called a voiding cystourethrogram (VCUG) at the end of the study to see if the VUR has decreased or disappeared
Your child is eligible to take part in the RIVUR study if he or she:
- Is at least 2 months old, but less than 6 years old
- Has had no more than two UTIs.
- Was treated for the first UTI for at least seven days with an effective antibiotic
- Has a VUR grade of I to IV
- Has no history of other renal injury or serious disease
- Has no allergies to sulfa medications, including trimethoprim-sulfamethoxazole
- Meets a few additional eligibility requirements
All study-related expenses will be covered by the RIVUR study.