The RIVUR study is a multicenter, randomized, double-blind, placebo-controlled study designed to determine whether small doses of antibiotics can prevent recurrent UTI and/or kidney damage.
The purpose of this study is to learn whether or not all children with VUR should be treated with long-term antibiotics.
There are 13 scheduled study contacts (5 study clinic visits and 8 follow-up phone calls) over a period of 24 months. If a study test cannot be scheduled on the day of a study clinic visit, you may have to return between study contacts.
A small amount of blood will be drawn from your child’s vein at each of the study clinic visits. The amount of blood collected will range from 5-10 ml (1-2 teaspoons) at the beginning and end of the study, and .5 ml (about 1/10 of a teaspoon) at the 6, 12, and 18-month visits. The total amount of blood drawn for study research during the 24 months will be 5 teaspoons or less.
In addition, your child will have a baseline, 12-month interim, and end-of-study 99mTc dimercaptosuccinic (DMSA) scans and an end of study VCUG. For detailed information about what these studies involve, please speak to your Study Coordinator.
Will I have to pay for visits, tests, or medications?
Your health insurance or the RIVUR study will cover most expenses. You may be responsible for the co-pay on some tests. You will be reimbursed for your time and travel expenses.
What happens if my child becomes ill while enrolled in the study?
For all illnesses, please seek medical care as you would normally. In the event of serious illness, your doctor will be informed which study medication your child is receiving (TMP/SMZ or placebo) if necessary to treat the illness appropriately. Even if your child is taken off of his/her study medication, he/she will still complete the study and continue with the study follow-up contacts.
What should I know about Vesicoureteral Reflux (VUR)?
Vesicoureteral reflux (VUR) is a condition in which urine goes up from the bladder into the ureters during urination. VUR is found in 30-50% of children who have had a urinary tract infection (UTI), and is thought to increase the risk of kidney damage when children have recurrent UTIs.
What should I know about the active study medication, Trimethoprim/ Sulfamethoxazole (TMP/SMZ)?
TMP/SMZ is commonly used for UTI prophylaxis and has an established record of safety in children. Common side effects include nausea, vomiting or diarrhea, mild allergic rash, and headache. Severe reactions (such as Stevens-Johnson Syndrome) are extremely rare. Because TMP/SMZ may increase photosensitivity, the use of sunscreen is advised.
Are there any medicines my child should avoid while in the RIVUR study?
TMP/SMZ may interfere with the following medications: Cyclosporine, Methotrexate, Phenytoin, Procainamide, Sulfonylureas, and Warfarin. If your child is taking any of these medications, please talk to your study doctor immediately.