Pediatric Trials Network study leads to FDA labeling change

April 9, 2015 – A 2011 study conducted by Daniel Benjamin, Jr., MD, MPH, PhD, and other DCRI researchers resulted in the relabeling of the antibiotic meropenem.

A study DCRI researchers conducted for the Pediatric Trials Network (PTN) has led to the relabeling of a widely used antibiotic.

Meropenem is a broad-spectrum antibiotic used in the treatment of many kinds of infections, including urinary tract, skin, bone, and stomach infections. It is approved for use in adults and older children and has long been prescribed for infants younger than three months despite a lack of data about the effects of the drug on these patients.

daniel-benjaminThe PTN was established in part to promote and support the studies needed to fill these gaps in the scientific literature. One of the first such studies was conducted by the DCRI’s Daniel K. Benjamin, Jr., MD, MPH, PhD, (pictured); P. Brian Smith, MD, MHS, MPH; Michael Cohen-Wolkowiez, MD; and colleagues from other institutions. Its purpose was to determine the optimal dosing regimen for meropenem in infants younger than 90 days old. Researchers were also interested in determining how safe the drug is for very young infants, especially when compared with imipenem, another broad-spectrum antimicrobial drug closely related to meropenem.

“We didn’t know how to dose it correctly, and as it turns out, we’ve been dosing it too low,” Benjamin said. “This study was an important step in putting solid data behind infant dosing regimens.”

The study, published in the October 2011 issue of The Pediatric Infectious Disease Journal, found that meropenem as dosed in the study is a safe alternative to imipenem for young infants with intra-abdominal infections. In December 2014, the U.S. Food and Drug Administration (FDA) changed the label for meropenem as a result of these findings.

Benjamin credited the PTN team as well as the DCRI’s Regulatory Services group with making the label change possible.

“Everyone did tremendous work in interfacing with the FDA and seeing this process through to the end,” he said.

More labeling changes will be on the way, Benjamin said. Data from PTN studies on hydroxyurea, fluconazole, acyclovir, and other drugs are currently being evaluated by the FDA. These kinds of changes will have meaningful effects for very sick infants and their families, he added.

“It’s lifesaving work,” he said.