Studying the safety, efficacy, and dosing of meropenem for the treatment of complicated intra-abdominal infections in infants.

Summary

Meropenem is a broad-spectrum anti-microbial drug used to treat intra-abdominal infections in young infants. Intra-abdominal infections are common in premature infants younger than three months of age and are often fatal. Meropenem, which effectively treats many types of bacterial infections, 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.

Brian Smith, MD, MPH, MHS, of the Duke Clinical Research Institute, presents the NICHD/BPCA meropenem study.

The purpose of the meropenem study, which ran from 2008 to 2011, 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 anti-microbial drug closely related to meropenem.

“Seizures are a known side effect [of imipenem], so we were particularly interested in looking to see if seizures were an adverse event we would see in this trial,” Smith said.

Testing young children presented certain challenges to researchers. Infants cannot provide biological specimens in the quantities that adults can. Only recently, Smith said, has medical technology allowed researchers to conduct studies using minute amounts of blood and other specimens.

“The blood samples that we used to measure the meropenem were very small,” he said. “They were 200 microliters, which is one-twenty-fifth of a teaspoon. We now have techniques that can measure concentrations of drugs in very small samples that weren’t available 20 or 30 years ago.”

The trial comprised 200 infants at 24 neonatal intensive care units across the United States. Each patient was given a dose of meropenem based on his or her gestational age at the time of birth and postnatal age at the time of the study. Researchers acquired blood samples from each infant when blood was being sampled as part of the children’s regular care.

Their findings suggested that meropenem as dosed in the study is a safe alternative for young infants with intra-abdominal infections. With this information in hand, researchers suggested new labeling guidelines to the Food and Drug Administration, which were implemented in March 2015.

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