Researchers seek children for a study of antibiotics for a urinary tract disorder

June 20, 2008

Researchers conducting a study to learn if children with a urinary tract disorder known as vesicoureteral reflux (VUR) should be treated with an antibiotic for an extended period of time are seeking to enroll more participants. The study, known as the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH).

VUR is the abnormal flow of urine from the bladder back up into the tubes that run to the kidneys. These tubes are called ureters. Normally, urine flows down the ureters to the bladder. VUR is the most common functional abnormality of the urinary tract in children. It is found in 30 percent to 50 percent of children with urinary tract infections (UTIs) and is thought to increase the risk of kidney damage when children have recurring UTIs. At least 30 percent of children who have at least one UTI will have a recurrence.

Scar tissue in the kidney, called renal scarring, occurs between 5 percent and 40 percent of the time when a child has a UTI. Scarring may build up with each infection and can lead to progressive kidney failure and the need for renal-replacement therapy, such as dialysis.

About 50 years ago physicians began to prescribe an ongoing regimen of daily antibiotics for children with VUR, based on the belief that treatment would prevent infections and reduce scarring and kidney failure. Unfortunately, the number of children developing kidney failure from VUR has not changed in that time, leading physicians to question the value of the practice and adding to concerns about increasing antibiotic resistance in the general population.

"The RIVUR study has the potential to help us understand how to provide the best care for tens of thousands of children diagnosed every year with this condition," said Marva Moxey-Mims, M.D., director of NIDDK's pediatric nephrology program in the Division of Kidney, Urologic, and Hematologic Diseases. "In addition to finding out if antibiotics reduce the risk of UTIs, we also need to understand the progression of renal scarring and the development of resistance to antibiotics in these children."

The researchers seek to enroll 600 participants. So far, 125 infants and children have joined the study. Participants must be between the ages of 2 months and 6 years and have had their first UTI within the six weeks before their first study visit. With the approval of 20 institutional review boards and an external data safety monitoring board charged with overseeing the safety of children in the trial, each participant receives a daily dose of an antibiotic or a placebo for up to two years. Children who develop recurring fever or other symptoms of infection or scar tissue buildup in the kidney will be switched from the study to routine antibiotic care and referred to a urologist, depending on the number of infections and degree of renal scarring.
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Learn more about VUR at http://kidney.niddk.nih.gov/kudiseases/pubs/vesicoureteralreflux/. For more information on the study, go to http://clinicaltrials.gov/ct2/show/NCT00405704?term=RIVUR&rank=1.

The National Institute of Diabetes and Digestive and Kidney Diseases, a component of the NIH, conducts and supports research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic, and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe, and disabling conditions affecting Americans. For more information about NIDDK and its programs, see www.niddk.nih.gov.

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH/National Institute of Diabetes and Digestive and Kidney Diseases

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