Randomized Intervention for Children with Vesicoureteral Reflux

Investigators:  

Amy Renwick, MD - Principal Investigator
Anita Reilly, MPH, CCRP - Study Coordinator                 

Background

Vesicoureteral reflux (VUR) is a condition in which urine goes up from the bladder into the ureters during urination. Reflux is graded on a scale of I to V. Grade I is the mildest degree of reflux and Grade V is the most severe degree of reflux. 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.

Currently, most children who are found to have VUR after a UTI 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 VUR who received either prophylactic antibiotics or surgery; an observation group (a group taking placebo medication) was not included in that study. There have been no well-designed research studies to show that long-term antimicrobial treatment is necessary in all children with VUR.

What we’re doing

This study provides the opportunity for 600 children at 19 Children’s Hospitals in the United States to receive close monitoring for urinary tract infections and their kidney health over a two-year period. All participating children will receive excellent care with very close follow-up and early treatment of urinary tract infections. Half of the children will be randomly (like the flip of a coin) assigned to a daily dose of an antibiotic and the other half will receive a daily dose of a placebo, a liquid that looks and tastes exactly like the antibiotic, but contains no medicine. Every six months, all of the children in the study will be monitored for urinary tract infections and the development of antibiotic resistance. At the beginning of the study, at the end of one year, and at the end of two years, all of these children will have their kidney functions monitored through blood tests and a DMSA kidney scan. This kidney scan does not require urinary catheterization.

During these two years, the parents of all participating children will have direct access to our study team, including kidney specialists, if there are any concerns of another urinary tract infection. The families of the participants will receive educational materials and scheduled phone calls from the study team.

How does my child qualify?

• A least 2 months of age, but less than 6 years (72 months) old upon enrollment
• First or second urinary tract infection (UTI) with either fever or associated symptoms
•  Most recent UTI within 112 days prior to enrollment
• Treated for the most recent UTI for at least 7 days with an effective antibiotic
• Vesicoureteral reflux (VUR) grade I-IV in at least one ureter
• No history of other renal injury or disease
• No other current or former medical conditions that could interfere with his/her response to the study medication
• No allergies to sulfa medications, including trimethoprim-sulfamethoxazole

What have we learned so far?

For a glimpse at what we’ve learned so far, watch the webcast “Urinary Tract Infection and Vesicoureteral Reflux: Are We Doing Enough or Too Much?” 

Need additional information or want to arrange an appointment?

Please Call Amy Renwick, MD, or Anita Reilly, MPH, CCRP at 302-651-4542.

To learn more, please read the patient information flyer.