Results of a small Johns Hopkins Children's Center study show that hospitalized children given high-dose IV infusions of the antibiotic vancomycin to treat drug-resistant bacterial infections face an increased risk for kidney damage—an often reversible but sometimes serious complication.
The findings, published in the December issue of the journal Annals of Pharmacotherapy, highlight the importance of prescribing the medication cautiously, the investigators say, and also underscore the need for newer, safer drugs to treat resistant infections.
“Our results bear out the difficult balancing act between ensuring the dose is high enough to successfully treat these serious and, at times, life-threatening infections against the small but real risk for kidney damage,” says study senior investigator Carlton Lee, Pharm.D., M.P.H., a pediatric clinical pharmacist and associate professor of pediatrics at the Johns Hopkins Children’s Center. “Ultimately, what we really need are new drugs that achieve the same therapeutic effect without taking a toll on the kidneys and other organs.”
Vancomycin, the researchers note, is a drug reserved for the treatment of bacterial infections that don’t respond to other medications, and it has been used safely for decades. But the spread of drug-resistant bacteria, such as MRSA, or methicillin-resistant Staphylococcus aureus, prompted new dosing guidelines in 2009, calling for treatment with higher doses of the drug when a resistant infection is suspected. While the new high-dose guidelines were written with adult patients in mind, many pediatric hospitals have applied the high-dose approach to the treatment of children to ensure the drug reaches high enough levels in the blood to successfully knock out the resistant germs and stave off the serious complications associated with such pernicious bacteria. The researchers also emphasize that this 30-year-old antibiotic can be a lifesaver for many patients with serious bacterial disease and that kidney damage is generally reversible when treatment stops.
The Johns Hopkins study, based on analysis of patient records of 175 children treated with vancomycin at Johns Hopkins between 2009 and 2010, found that 14 percent developed kidney damage.
“The results of our study highlight the need for trials that provide pediatric experts with the evidence needed to make informed treatment and dosing decisions, ones that are based on solid data in children rather than on extrapolation from adult patients,” says study lead author Elizabeth Sinclair, Pharm.D., a pediatric clinical pharmacy specialist at Texas Children’s Hospital who conducted the research while training at Johns Hopkins.
--Sarah Hagerty