A major new pediatric clinical trial, funded by the National Institutes of Health (NIH) and published this week in the New England Journal of Medicine (NEJM), has “major implications” for the treatment of urinary tract infections (UTIs) in millions of American children, according to a Children’s Hospital of Michigan pediatrician-researcher who played a key role in the study, which was initiated nine years ago.
The largest clinical trial of its kind ever to be conducted in the world, the study provides convincing evidence that children with a common urinary-tract abnormality known as “vesicoureteral reflux” (or “VUR”) experience a significantly reduced risk of developing frequent UTIs when treated with long-term low-dose antibiotics.
Because about one-third of children diagnosed with UTIs are also found to have VUR (a chronic condition in which urine refluxes from the bladder and spills back into the kidney, thus increasing the risk of UTIs and renal scarring), treating children with VUR with daily, low-dose, long-term antibiotics can be effective in protecting them from urinary tract infections, according to the authors of the study.
“This newly published study has major implications for the management of UTIs in children,” said Dr. Mattoo, who served as chair of the study’s Principal Investigators Committee. “Our clinical trial analyzed pediatric research data collected during 6 years at 19 different sites in the United States.,” said Dr. Mattoo, “and what we found was that children with VUR who received antibiotics long-term were 50% less likely to develop recurrent UTIs.”
“We know that UTIs can be a significant health problem for kids because of the medical complications that often accompany them. Such recurring infections can also cause significant discomfort for affected children, along with frequent visits to emergency rooms, which add to the already soaring cost of medical care.”
While noting that more than 3 percent of all American children develop UTIs each year and that their infections account for more than 1 million visits to pediatricians annually (according to the U.S. Department of Health and Human Services), Dr. Mattoo said, “This health problem affects tens of millions of kids each year, and up until now, there has been no study like this to show convincingly that treating children, who have both UTIs and VUR with long-term, low-dose antibiotics reduces their risk of infections significantly.”
“There has been a great deal of debate on that question during the past ten to fifteen years, but this new study should end that debate. The data in the study are compellingly clear – and will help clinicians achieve appropriate management and counseling of children after their first urinary tract infection.”
Dr. Mattoo, who serves as chief of Pediatric Nephrology and Hypertension at the Children’s Hospital of Michigan at the DMC and professor of pediatrics for the Wayne State University School of Medicine, is a nationally recognized researcher in the field of pediatric kidney disease. He pointed out that the prospective, randomized, placebo-controlled study “Antimicrobial Prophylaxis for Children with Vesicoureteral Reflux” looked at 607 children “with vesicoureteral reflux diagnosed after UTI,” between 2007 and 2011.
The study found that the children who received long-term antibiotics developed 50% fewer UTIs than the children in the control group who did not receive the antibiotic therapy.
“I think the implications of the study send a very hopeful message to all of us who have struggled so hard in recent years to determine just how effective antibiotic prophylaxis is in protecting children with VUR from recurrent urinary tract infections and renal scarring,” said Dr. Mattoo.
“According to the study, we now have a much clearer understanding of the relationship between UTI and VUR, and that has clinical implications that are very positive, indeed.”
Dr. Mattoo was also careful “to thank the hundreds of parents who so generously helped the investigators gather data at centers all across the country, along with the team of researchers, study coordinators, research assistants, and office staff who did so
much work at children’s health care facilities around the nation.”
The results of the study were also presented at the May 3-6, 2014, Pediatric Academic Societies Congress in Vancouver, Canada, where Dr. Mattoo will outline the potential impact of the study on the current guidelines for the management of urinary tract infection and vesicoureteral reflux in children.
After describing the groundbreaking NEJM study as “compelling evidence of how the Children’s Hospital of Michigan is continuing to provide national leadership in pediatric medical research,” the Children’s Hospital of Michigan’s Chief Executive Officer Larry Gold said, “This is the kind of breakthrough that has the potential to spare millions of children – and their longsuffering parents – from the discomfort and anxiety caused by frequent urinary tract infections.” This study “shows exactly why the Children’s Hospital of Michigan is so dedicated to pediatric research, along with quality of care. This breakthrough powerfully demonstrates how great research and great clinical care work hand in hand in order to ensure the very best possible outcomes for patients.”
About the Children’s Hospital of Michigan, www.childrensdmc.org
For more than 125 years, the Children’s Hospital of Michigan is the first hospital in the state dedicated exclusively to the treatment of children. With more than 40 pediatric medical and surgical specialties and services, the hospital is a leader internationally in neurology and neurosurgery, cardiology, oncology, and diagnostic services; it is ranked one of America’s best hospitals for children and sees more children than any hospital in the state. More Michigan pediatricians are trained at the Children’s Hospital of Michigan than at any other facility.
Children’s Hospital of Michigan is one of eight hospitals operated by the Detroit Medical Center (DMC). The DMC is proud to be the Official Healthcare Services Provider of the Detroit Tigers, Detroit Red Wings and Detroit Pistons.
About Wayne State University, www.wayne.edu
Wayne State University is a premier urban research institution offering more than 400 academic programs through 13 schools and colleges to nearly 32,000 students. Its School of Medicine is the largest single-campus medical school in the nation with more than 1,200 medical students. In addition to undergraduate medical education, the school offers master’s degree, Ph.D. and M.D.-Ph.D. programs in 14 areas of basic science to about 400 students annually.