Researchers Seek Participants for a
Study of Antibiotic Use in Children with a Urinary Tract Disorder
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
or second UTI within 10 weeks or 112 days of study enrollment.
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.
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.
Notice: At the request of the Institute, on June 23, 2008, the third sentence of the sixth paragraph in this release was changed from the following to the version posted above: 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.